This blog highlights our customer story, “LEX Diagnostics Boosts Efficiency by Modernizing its Requirements Tool with Jama Connect”

LEX Diagnostics Boosts Efficiency by Modernizing its Requirements Tool with Jama Connect

“It’s very compatible with the sort of startup model where everybody will be doing a little bit of everything. The person with the best skill set is the one who solves a particular problem.” – Tim Schuller, VP of Engineering, LEX Diagnostics

About LEX Diagnostics

LEX Diagnostics is redefining point-of-care diagnostics with its ultra-fast PCR system. Their launch product, the VELO system, delivers positive results for Flu A, Flu B, and COVID-19 in as little as six minutes, enabling cost-effective decisions during a single appointment.

Customer Story Overview

After inheriting an existing requirements management tool, LEX Diagnostics sought to modernize their approach. Switching to Jama Connect provided a user-friendly platform with direct product support and flexible licensing that aligned with their agile goals.

With Jama Connect, Users Experience:

• A Modern, Intuitive Interface that empowers users to manage requirements, create documents, and enhance collaboration without a steep learning curve.
• Flexible Licensing and Widespread Adoption that allows the entire team to contribute to projects, creating a single source of truth and improving internal knowledge sharing.
• Responsive, Expert Support that provides clear answers and reliable timelines, saving weeks of project time and eliminating administrative delays.

RELATED: Traceable Agile™ – Speed AND Quality Are Possible for Software Factories in Safety-critical Industries

Challenges

LEX Diagnostics encountered hurdles in integrating their existing tool with their agile, startup environment. The team identified several areas where an improved solution could better support their workflows and rapid development pace.

• Need for Responsive Support Jama Software’s flexible support model was a key advantage at important points in LEX’s development journey allowing the company to avoid manual workarounds which had historically been necessary and highlighting the importance of a partner that provides direct and timely product support.
• Complexity Impacting Usability The LEX team found the Jama Connect interface easy and intuitive to navigate, which encouraged adoption by users who weren’t full time administrators resulting in the tool being more widely used across the organization. Jama Connect reduces the steps required to execute routine tasks, saving LEX significant time and money.
• Need for Scalable Licensing Startups like LEX thrive on agility and collaboration, requiring tools that adapt to their dynamic workflows. Thanks to a flexible licensing model, Jama Connect allowed the entire team to participate directly in the development process, ensuring that critical reviews and updates happened within the platform itself. The software removed barriers to access and kept everyone aligned with a single source of truth.

“Our head of software…just figured Jama Connect out himself in about 15 minutes. It’s just night and day with simplicity.” – Tim Schuller, VP of Engineering, LEX Diagnostics

Solution

LEX Diagnostics decided it was time to update its requirements management tools and chose Jama Connect, supported by internal champions with positive prior experiences with the platform.

• Seamless Onboarding and Hands-On Support: Following a trial where the team could test the platform’s full capabilities, Jama Connect’s tailored onboarding and hands-on support ensured a smooth transition.
• An Intuitive, User-Friendly Platform: The simplicity of Jama Connect offered immediate value to the engineering team, allowing them to focus on innovation rather than tool management.
• A Flexible Licensing Model: Jama Connect’s flexible licensing model, including unlimited reviewer seats, suited LEX Diagnostics’ startup environment, fostering collaboration across departments.

“It’s a useful confidence boost to see that the workflows we’ve built in Jama Connect closely align with standard medical device and regulatory workflows, reinforcing trust in our approach.” – Tim Schuller, VP of Engineering, LEX Diagnostics

RELATED: Traceable Agile™ – Speed AND Quality Are Possible for Software Factories in Safety-critical Industries

Outcomes

Since adopting Jama Connect, LEX Diagnostics has seen significant improvements in its processes, team morale, and confidence in meeting regulatory requirements.

• Improved Adoption and Internal Knowledge: Flexible licensing has driven widespread adoption. Teams now use Jama Connect for internal software and hardware development — projects they previously managed in disparate documents. “It’s very compatible with the sort of startup model where everybody will be doing a little bit of everything,” Schuller explained. “The person with the best skill set is the one who solves a particular problem.”
• Increased Efficiency and Reduced Timelines: The direct support and user-friendly interface have streamlined administrative tasks. Schuller estimates the responsive support from Jama Connect saved four to five weeks of potential delays. When the FDA requested further details during review of their 510(k) submission, generating documents from Jama Connect was faster and easier.
• Enhanced Regulatory Confidence: With built-in templates aligned with standards like ISO 14971, Jama Connect gives the team a validated framework for their workflows that has provided a “useful confidence boost.” The ability to easily version changes within the platform has also freed them from manual paperwork tracking and potential audit complexities.

Ready to see how Jama Connect can modernize your development process? Let’s connect.

TO DOWNLOAD THIS ENTIRE STORY, VISIT:
LEX Diagnostics Boosts Efficiency by Modernizing its Requirements Tool with Jama Connect

The post LEX Diagnostics Boosts Efficiency by Modernizing its Requirements Tool with Jama Connect® appeared first on Jama Software.

In this blog, we recap our recent customer story, “Dexcom Achieves 60% Systems Engineering Efficiency Improvement with Jama Connect” – Click HERE to download it in its entirety!

Dexcom Achieves 60% Systems Engineering Efficiency Improvement with Jama Connect^®

Centralized requirements, Live Traceability™, and enhanced collaboration power Dexcom’s development of life-changing CGM technology.

About Dexcom:

• Develops, manufactures, produces, and distributes Continuous Glucose Monitoring (CGM) systems for diabetes management
• Headquartered in San Diego, California, USA

Dexcom was founded in 1999 to make diabetes management better with the world’s first real-time, integrated CGM system, the Short-Term Sensor (STS). This, and subsequent generations of the device now named the G series, combines hardware, software, and firmware to deliver an optimal user experience for making decisions about insulin and food intake.

After most of its history as a single product company, Dexcom developed Stelo, a wearable glucose biosensor available over-the-counter for people with type 2 diabetes who don’t require insulin.

RELATED: Buyer’s Guide: Selecting a Requirements Management and Traceability Solution for Medical Device & Life Sciences

CHALLENGES

• Siloed Tooling: A document-centric approach and legacy tools created barriers to adoption and collaboration across engineering disciplines.
• Traceability Gaps: Lack of a unified view of traceability made change management complex and created confusion across teams.
• Regulatory Overhead: Manual processes for generating regulatory document templates caused significant delays and administrative burden.
• System Complexity: Managing a complex set of interconnected hardware, software, and embedded requirements lacked a single source of truth.
• Disconnected Ecosystem: Poor connectivity between requirements management and other engineering tools hindered end-to-end visibility.

Dexcom’s products combine software, hardware, and firmware, each with their own requirements and tests that must be managed and traced for compliance. As the company scaled, the existing processes, which relied on a mix of legacy tools, spreadsheets, and documents created information silos. Teams were often uncertain if they were working with the latest requirements, leading to rework and inefficiencies.

Generating audit-ready documents for regulatory compliance was a time-consuming, manual effort. The engineering and quality organizations invested significant time in manual documentation to ensure their products were always safe, effective, and compliant.

“We have a lot of smart people who joined Dexcom with expectations about doing great things. Having them spend a significant amount of their time manually copying and pasting in spreadsheets and Word documents is not the best use of their talent and expertise,” says Sri Harsha Maramraju, Senior Manager, Systems Design Engineering at Dexcom

RELATED: Application of Risk Analysis Techniques in Jama Connect to Satisfy ISO 14971

EVALUATION CRITERIA

• A central repository to keep all stakeholders informed of requirements status and changes.
• An intuitive user experience to encourage broad adoption and cross- functional collaboration.
• Full end-to-end traceability of all requirements and tests to support design controls and compliance.

Dexcom identified the need for a modern, centralized platform to manage requirements, tests, reviews, and documentation. The goal was to find a system with an intuitive interface and clear traceability to improve efficiency, stakeholder engagement, and compliance readiness. After a thorough evaluation of several leading solutions, the stakeholders selected Jama Connect. The platform’s exceptional usability, robust traceability visualization, and deep-rooted acceptance in the medical device industry made it the clear choice.

Key evaluation areas where Jama Connect excelled were its ease of use and powerful document generation capabilities. Another critical factor was its ability to provide clear visibility into the end-to-end traceability of all hardware, software, and firmware requirements and tests.

“Other tools have traceability, but only Jama Connect has a visual, configurable model that shows exactly what traceability looks like and accommodates our product’s complex configuration.” Sri Harsha Maramraju – Senior Manager, Systems Design Engineering at Dexcom

For regulatory compliance, Jama Connect stood out with its out-of-the-box framework for medical device development, which simplifies alignment with stringent quality and safety standards.

“The built-in support for standards like ISO 14971 and the validated package included with Jama Connect give us the confidence to demonstrate that we are following industry best practices,” says Maramraju.

RELATED: Jama Connect for Medical Device Development

OUTCOMES

• Streamlined change management and reviews for monthly releases using Jama Connect’s Review Center.
• Achieved a 60% productivity boost for the systems engineering team, enabling faster project completion.
• Successfully migrated active projects to Jama Connect, ensuring a smooth transition to a modern platform.
• Driving reuse of requirements and tests across projects to support product line engineering (PLE) goals.

“If you’re building a centralized ecosystem for product development and design controls for the long term, you can rely on Jama Connect. Its usability, traceability, and industry-wide acceptance make it a cornerstone of our engineering process.” – Sri Harsha Maramraju – Senior Manager, Systems Design Engineering at Dexcom

Dexcom now depends on Jama Connect to efficiently manage requirements, changes, and reviews for its aggressive release cadence. Having one centralized place for these activities has improved systems engineering efficiency by 60%. The intuitive collaboration and review functionality in Jama Connect has increased stakeholder engagement. Quality and Regulatory teams now actively participate in the process within the tool, appreciating the structure and auditability it provides. “The conversation has shifted. Instead of discussing tool limitations, our teams now have productive, data-driven discussions about the work itself within Jama Connect. When other departments see what we are doing, they ask how they can get their projects onto the platform too,” says Maramraju.

Jama Connect’s Live Traceability™ has enabled Dexcom to track requirements through all stages of development, with integrations that sync requirements data to development activities in other tools like Jira. Looking forward, Dexcom is leveraging Jama Connect to drive reuse and synchronization of requirements across different platforms, a key step toward their product line engineering goals.

TO DOWNLOAD THE ENTIRE CUSTOMER STORY, VISIT:
Dexcom Achieves 60% Systems Engineering Efficiency Improvement with Jama Connect

The post Dexcom Achieves 60% Systems Engineering Efficiency Improvement with Jama Connect® appeared first on Jama Software.

In this blog, we recap our customer story, “INBRAIN Chooses Jama Connect® to Provide Clarity, Stability, and Confidence in Quality Control for Neural Implant Systems Development.”

INBRAIN Chooses Jama Connect ^® to Provide Clarity, Stability, and Confidence in Quality Control for Neural Implant Systems Development

INBRAIN Neuroelectronics develops GRAPHENE NEURAL implant systems for central and peripheral neuroelectronic applications including autonomous BCI Therapeutics to restore movement control and other important lost functions in Parkinson’s disease, Epilepsy or Stroke in addition to organ related therapeutics

Customer Story Overview

The company started looking for a requirements management tool to use in developing their first product. They knew that building implants would involve a huge number of requirements to be written, checked, reviewed, and iterated on. Connecting to related software development activity in Jira and test management systems would be critical to ensuring quality and maintaining traceability.

They determined that using Excel for requirements and test traceability would be too cumbersome, time consuming, and risky. Ensuring regulatory compliance and product quality was too important for successful product development and delivery to rely on a manual, document-based process prone to human mistakes.

INBRAIN chose Jama Connect because it greatly increased confidence in quality control by enabling the entire team to work collaboratively and efficiently on requirements, tests, and risk management. This provided the stability for the team to focus on the development effort rather than worry about data integrity or quality control issues.

With Jama Connect, Users Experience:

• Greater confidence in quality control thanks to distributed collaboration that enabled the entire team to work in parallel with consistent, shared, up-to-date information
• Ability to start working immediately after fast configuration and setup of integrations assisted by Jama Software’s Services team
• Centralized platform for integrated requirements, tests, and risk management professionally supported by Jama Software’s Support team

“The massive collaboration in Jama Connect, where everything is controlled and checked and where reuse is supported, makes the whole management of requirements much easier.”
– MARTIJN HAZENBERG – HEAD OF EMBEDDED ENGINEERING, INBRAIN

RELATED: Buyer’s Guide: Selecting a Requirements Management and Traceability Solution for Medical Device & Life Sciences

Challenges

Complex, high volumes of requirements and tests.

When developing highly complex medical devices, the use of Excel for manual tracing of large volumes of requirements and tests through multiple iterations and reviews would have been too time-consuming, cumbersome, and risky from a compliance and quality perspective.

“We wanted to avoid spending so much time on manual efforts such as modifying data in Excel sheets and performing manual traceability. By using Jama Connect, all of that wasted time disappears, and we can focus on the things that truly matter, such as our development effort.” – ALBERT MOLINS – SYSTEMS ARCHITECT, INBRAIN

Evaluation

Integrated solution for managing requirements, tests, and risks in connection with Jira and test automation systems.

The evaluation demonstrated that Jama Connect could provide the integrated, efficient, collaborative solution that the company needed for both current and future needs. The team also appreciated how quickly Jama Software’s Solutions Architect and Support staff responded to questions and requests during and after the evaluation.

“Jama Connect has given our team much greater clarity, stability, and confidence in control quality to focus on development.”
– ALBERT MOLINS – SYSTEMS ARCHITECT, INBRAIN

RELATED: Jama Connect for Medical Device Development

Outcomes

With Jama Connect, the INBRAIN team has experienced the following benefits:

• Confidence in the development process based on consistent, shared, up-to-date information
• Ability to start working immediately after fast configuration and setup of integrations
• Distributed collaboration enabling the entire team to work in parallel managing requirements and tests used to prepare regulatory documents
• Centralized, professionally supported platform for integrated requirements, tests, and risk management

Experiencing the distributed collaboration in Jama Connect gave the entire team confidence to focus on the development work that mattered. During verification of requirements, everyone was engaged in running test cases and other activities in parallel to ensure quality. They continue to benefit from continuous support available from their local Jama Software consultant whenever they have questions that could hinder development progress.

TO DOWNLOAD THE ENTIRE CUSTOMER STORY, VISIT:
INBRAIN Chooses Jama Connect to Provide Clarity, Stability, and Confidence in Quality Control for Neural Implant Systems Development

The post INBRAIN Chooses Jama Connect® to Provide Clarity, Stability, and Confidence in Quality Control for Neural Implant Systems Development appeared first on Jama Software.

In this blog, we partially recap this customer story, “Vave Health Migrates to Jama Connect^® to Accelerate Development and FDA Clearance” Read the entire story HERE.

Vave Health is committed to revolutionizing the physician-patient experience through innovative, industry-transforming technologies. Their innovative handheld ultrasound device packs the ability to wirelessly connect with your Android or iOS smartphone or tablet.

After initially selecting Matrix Requirements, Vave Health found themselves constrained by the tool’s limited functionality and were ready for a change. Following a requirements management market analysis, Jama Connect^® was selected and onboarded due to its ease of use and industry-leading functionality.

Read this customer story to see how now, with more confidence in their processes, Vave health has achieved the following outcomes:

• Accelerate the release cadence from what previously took a couple weeks, down to a day or two
• Decrease generation of trace matrices from 30 days to one per project
• Scale development process with the ability to run multiple projects in parallel
• Maintain traceability and instantly identify coverage for verification and validation of requirements to respond to action items sooner in development

VAVE HEALTH CUSTOMER STORY OVERVIEW

CHALLENGES WITH MATRIX

• Reports, such as a traceability matrix, were taking too long to generate
• The steep learning curve caused most people to revert to working in Word and Excel
• Inability to develop parallel projects and reuse data between releases, contributed to duplicated work and slower-than-desired release cadence

SELECTION CRITERIA

• A solution that would scale with their growth
• Quick-to-adopt and easy-to-use 
• Strong market presence
• Ease of data migration

OUTCOME + FUTURE

• Accelerate the release cadence from what previously took a couple of weeks, down to a day or two
• Decrease generation of trace matrices from 30 days to one per project
• Scale development process with the ability to run multiple projects in parallel
• Maintain traceability and instantly identify coverage for verification and validation of requirements to respond to action items sooner in development

RELATED: 2023 Predictions for Medical Device Product Development

CHALLENGES

In the early days of Vave Health, the development team originally selected Matrix Requirements due to its low cost. While the tool was sufficient for managing their requirements in the preliminary stages of development, as the company began to scale, it became apparent that they needed a more mature, enterprise-grade solution with more robust capabilities.

The main challenges that Vave Health had which led them to seek out a new solution were:

• Reports, such as a traceability matrix, were taking too long to generate
• Steep learning curve caused most people to revert to working in Word and Excel
• Inability to develop parallel projects and reuse data between releases, contributed to duplicated work and slower-than-desired release cadence

As a small team, they did not have dedicated staff to manage requirements – it was a shared responsibility. With Matrix Requirements, the learning curve was so steep, only a few people were able to use it. Even then, it was used similarly to an Excel spreadsheet.

“Matrix Requirements was difficult to use, and it limited our ability to easily extract reports and quickly show traceability. The whole process just took too long,” said Craig Loomis, Vice President of Product at Vave Health.

“One of the deliverables in getting our product released is generating the trace matrix. With Matrix Requirements, it was very cumbersome,” said Sandhya Mitnala, Head of Quality and Regulatory at Vave Health. “We realized that something that should have taken one or two days, and managed through the project, took us almost a month. It was a very manual process.”

Additionally, as the team grew and the development work went from singular to multiple projects, the team ran into limitations using Matrix Requirements.

“One thing we didn’t initially think about when selecting Matrix Requirements was the ability to have multiple projects in motion at the same time,” said Loomis. “Although it was technically possible, there was no good way to extract the trace matrix and manage revisions across different projects at the same time in parallel.”

RELATED: FDA Updates to the Medical Device Cybersecurity Guidance

SELECTION CONSIDERATIONS

In order to overcome the limitations of their current tool, the team set out to find a solution that could meet their current needs and grow with them as they expanded in the market.

“The startup world is unique in that you’re trying to do so much more with fewer resources. Sometimes you do need to leverage technology to automate things that larger companies would be
able to throw bodies at,” said Loomis.

When it came time to evaluate the available solutions in the marketplace, things moved quickly.

“From my experience working with Jama Software^® at other companies, and my coworkers’ similar experiences, we wanted to move to a more automated solution and Jama Software was on everyone’s mind,” said Mitnala. “It was a very easy choice for us. All of the solutions we looked at, outside of Jama Connect^®, were ruled out quickly,” shared Loomis.

During the evaluation process, the Vave Health team was able to access a sandbox account created specifically for them, so they could test out the solution to make sure it was the right fit.
Because there were so many things already in motion, the team wanted to ensure that data migration would not be an issue, so they could keep moving quickly.

“Before we even signed a contract, we spent time in Jama Connect and had a lot of confidence in moving forward. We knew that our data would be migrated easily, and we wouldn’t be putting our projects at risk,” said Loomis.

Although Matrix Requirements supported some initial needs, the team knew that in order to derive the value they needed, it was time to up-level their tool for requirements management and systems engineering. The return on investment for Jama Connect, a robust, yet easy-to-use platform (which comprised the feature set and functionality they required) would increase efficiencies, simplify compliance, reduce risk, and ultimately speed time-to-market, paying dividends in the long run.

“As a startup, the one thing you must ensure is that you are able to move fast. You’re learning the market, you’re working against your competitors, and speed to market is critical. Especially where there are things that can be automated – that’s where you want to invest,” said Loomis.

To read the entire outcome from Vave Health’s choice of Jama Connect, read the entire customer story here:
Vave Health Migrates to Jama Connect^® to Accelerate Development and FDA Clearance

The post Vave Health Decides to Migrate to Jama Connect® to Accelerate Development and FDA Clearance appeared first on Jama Software.

Jama Software is always looking for news that would benefit and inform our industry partners. As such, we’ve curated a series of customer and industry spotlight articles that we found insightful. In this blog post, we share an article, sourced from Spyrosoft, titled “CE marking for Medical Device Software: a step-by-step guide” – originally authored by MAŁGORZATA KAWAŁKOWSKA.

CE Marking for Medical Device Software: A Step-By-Step Guide

The recent introduction of EU MDR brought many changes to the CE marking certification process for medical devices. There are more requirements to fulfil, which makes the process more complex and much more time-consuming.

To avoid a scenario where the only thing that stops you from releasing your Medical Device Software to the market is the ongoing CE marking certification, you should know when to take the first steps in this process and how to include it in your overall business strategy.

From this blog post, prepared based on an interview with Krzysztof Minicki, Director of Healthcare and Life Sciences, you’ll get to know the steps of the CE marking process for Medical Device Software. You’ll also learn your responsibilities as a manufacturer, and thus get a better understanding of how to plan and optimise the process to avoid possible bottlenecks.

ToC:

1. Does your software need a CE marking certification?
2. How to get the CE marking certification for Medical Device Software in the EU?
3. How to do CE marking self-certification?
4. How long is the CE marking certification valid?
5. How much does it cost to get CE marking certification?
6. How long does the CE marking certification process take?
7. Need support in the CE marking certification process?

Does your software need a CE marking certification?

Since the introduction of EU MDR in May 2021, the software is now classified as an active medical device. All Medical Device Software that is released to the EU market is required to have the CE marking. Otherwise, it cannot be sold within the EU.

CE MARKING AFTER BREXIT

As of January 1st, 2021, any type of business collaboration between the UK and EU countries got a lot more complicated. So did the CE marking process, which has gone into the transition period ending on January 1st, 2023 – medical companies operating on the British market will be obliged to receive UKCA certification instead of CE marking, with medical products sold in Northern Ireland still requiring the latter. Healthcare products that require to be assessed by a Notified Body will need to be check by an UK Notified Body rather than a EU one.

How to get the CE marking certification for Medical Device Software in the EU?

As a Medical Device Software manufacturer, regardless of whether or not you outsource the manufacturing process, you are responsible for acquiring the CE marking.

In general, the path towards obtaining the CE marking depends on the medical device’s class. Since, in the light of the EU MDR, Medical Device Software is considered as an active medical device, the majority will undergo the upclassification and will belong at least to class IIa.

As per the EU MDR rules, medical devices from classes IIa, IIb and III, have to go through the conformity assessment conducted by a Notified Body. A Notified Body is a third-party organisation, accredited by a European Competent Authority, that checks compliance with the MDR. As a medical device manufacturer, you can select which Notified Body you want to do the assessment for you.

Now, let’s move on now to what the CE marking process for Medical Device Software looks like step by step.

RELATED: 2023 Predictions for Medical Device Product Development

How to do CE marking via self-certification?

1: IMPLEMENT A QUALITY MANAGEMENT SYSTEM

As you determine the classification of your Medical Device Software and appoint a person responsible for regulatory compliance in your organisation, the next step is to create and implement a Quality Management System in accordance with Annex VIII of the MDR and ISO 13485. The compliance must be assessed and certified by a Notified Body. Moreover, the Quality Management System must include Clinical Evaluation, Post Market Surveillance and Post Market Clinical Follow-up plans.

2: PREPARE THE TECHNICAL FILE

In the Technical File you have to include the information about the Intended Use of your Medical Device Software, all the testing reports as well as the Clinical Evaluation Report, your risk management plan and other information specified in Annex II of the MDR.

3: REGISTER IN THE EUDAMED DATABASE

Register your Authorised Representative who will handle the regulatory matters as well as your company as a medical device manufacturer in the EUDAMED database. It’s important to note that the authorised representative is mandatory only for importers outside of the EU.

You don’t necessarily have to do it at this point. It can also be done earlier or later in the process.

4: PREPARE A DECLARATION OF CONFORMITY

The next step for you, the manufacturer, is to prepare a Declaration of Conformity. It’s a legally binding document in which you affirm that your Medical Device Software is compliant with the MDR. At this stage, your product becomes officially CE marked.

5: REGISTER THE MEDICAL DEVICE SOFTWARE IN THE EUDAMED DATABASE

Now it’s time to register your software in the EUDAMED database. Keep in mind, that the UDI number must be placed, for example, in the “footer” or “About” section or other visible and easy-to-access places.

That’s it – your Medical Device Software is ready to be sold on the EU market. Your duty as a manufacturer is now to keep it safe and effective. In this regard, the EU MDR requires that manufacturers conduct Post Market Surveillance Activities. Also, each year you will undergo a Notified Body surveillance audit to ensure continuous compliance with the EU MDR. If you fail to pass it, your CE marking may become invalid.

During the transitional period, the manufacturers are required to perform the Clinical Evaluation and Post Market Surveillance Activities required by MDR, even though their CE marking certification for class I is still valid.

How to CE mark your software if it falls into a higher risk class?

The certification of software that belongs to a higher risk class requires the involvement of a Notified Body. A Notified Body shall audit the quality management system to determine whether it meets all the regulatory and product requirements. If the quality management system conforms to the relevant regulatory provisions, the notified body shall issue an EU quality management system certificate. After that, the declaration of conformity can be signed. Then, the product can be registered in the Eudamed database and finally introduced into the market.

Specific requirements depend on the characteristics and the level of complexity of a product as well as the risk associated with using it, which directly translates into the scope and timeframe of the audit.

How long is the CE marking certification valid?

The CE marking certification for classes IIa, IIb and III is valid for up to five years. After the five-year period, the registration of the certification must be renewed. It’s key to have it on the radar and plan the process in advance. It’s recommended to start the registration renewal at least six months before the certification expires.

How much does it cost to get CE marking certification?

The total cost of the CE marking certification process is proportionate to a device’s class. The higher the class, the bigger the risk and the more complex the process. Hence, the cost is also higher. The CE Marking certification is the most expensive for class III devices and can reach even tens of thousands of dollars.

RELATED: Euro Roundup: MDCG Publishes Guidance on MDR, IVDR Authorized Representative Requirements

How long does the CE marking certification process take?

Since there are still very few Notified Bodies, conducting the conformity assessment may take quite a long time. The time to begin a Notified Body audit varies between half a year and a year. In comparison, under the MDD it was usually a quarter. The time between an audit and approval may take up from two to even seven months.

Why so long? The EU MDR brought in more requirements, especially for the QMS. This makes the whole process more complex and time-consuming.

One of the reasons why it takes so long is also that there are few Notified Bodies that got already accredited in compliance with the new MDR requirements.

Currently, the MDR requires Notified Bodies to make their price list public. However, it’s worth noting that it includes the hourly rates. It’s especially important to keep in mind when introducing a product to the market for the first time (also for the first time since the MDR came into force) as it requires more than one audit to be performed. Firstly, the Notified Body checks the readiness for certification and after a few months it conducts the certification audit. It significantly impacts the cost. The yearly surveillance or recertification audits are performed once per year.

In total, the CE marking certification process may last more than a year. It’s important to take it into consideration when planning your business strategy. For example, you can optimise the process by creating an MVP first and start the CE marking Certification in the meantime, while at the same time developing your product further on.

Need support in the CE marking certification process?

We provide a technical file ready to be assessed for conformity by a Notified Body. Moreover, our specialists can conduct an independent conformity assessment before the official one to check what areas need improvement.

The software we create is compliant with all legal requirements, especially the IEC 62304 and ISO14971. In addition, we provide a Technical File and offer consultation and support with completing the CE marking certification process.

For more information, use the form at the bottom of this blog to contact Krzysztof Minicki, Director of Healthcare and Life Sciences.

The post CE Marking for Medical Device Software: A Step-By-Step Guide appeared first on Jama Software.

Jama Software is always looking for news that would benefit and inform our industry partners. As such, we’ve curated a series of customer and industry spotlight articles that we found insightful. In this blog post, we share an article, sourced from Engadget, titled “TSMC is building a second chip plant to meet US semiconductor demand” – originally published on December 6, 2022, and authored by Steve Dent.

TSMC is Building a Second Chip Plant to Meet US Semiconductor Demand

The expansion marks one of the largest direct foreign investments in the US.

The White House and Taiwan Semiconductor Manufacturing co. (TSMC) have announced plans to build a second chip plant in Arizona, AZCentral has reported. That will boost the company’s investment in the state from $12 billion to $40 billion, while heavily reducing US reliance on semiconductor imports.

Both TSMC factories combined will produce 600,000 wafers per year. “At scale, these two [plants] could meet the entire U.S. demand for U.S. chips when they’re completed,” the National Economic Council’s Ronnie Chatterji told CNBC. “That’s the definition of supply chain resilience. We won’t have to rely on anyone else to make the chips we need.”

The newly announced factory will produce cutting-edge 3-nanometer chips by 2026. The expansion marks one of the largest direct foreign investments in the US and the largest in Arizona. TSMC recently upgraded its plans at its first facility as well, announcing it will now manufacture 4-nanometer instead of 5-nanometer wafers. The first chips are set to be manufactured there starting in 2024, with Apple and NVIDIA reportedly among the first customers.

RELATED: Jama Connect^® for Semiconductor Software: Modernize and Digitize the Requirements Management Process

The CHIPS and Science Act allotted $52.7 billion in loans and other incentives, plus billions more in tax credits, to encourage US semiconductor manufacturing investment. The legislation aims to boost private financing in chip manufacturing in the US.

President Joe Biden is set to visit the site of TSMC’s first plant later today, but the White House announced other related news yesterday. The US Department of Commerce and the European Commission are striking a deal to implement an “early warning mechanism” related to semiconductor chain disruptions following a pilot program last summer. The aim is to improve forecasting of semiconductor supply and demand to achieve a balance between the two.

RELATED: Jama Connect^®: Accelerating Systems Development with Requirements Management and Live Traceability™

At the same time, the EU and US are implementing a “transparency” mechanism around public support provided to the chip sector. In other words, one side won’t blindside the other with unexpected semiconductor subsidies that could put either at a competitive disadvantage. A similar issue came up during a recent visit by French President Macron, as EU leaders complained that the US Inflation Reduction Act was unfair to non-American companies.

The post TSMC is Building a Second Chip Plant to Meet US Semiconductor Demand – SUNSETTED appeared first on Jama Software.

Jama Software is always looking for news on our customers that would benefit and inform our industry partners. As such, we’ve curated a series of customer spotlight articles that we found insightful. In this blog post, we share a press release, sourced from Cision Distribution by PR Newswire, about one of our customers, magniX titled “magniX Powers First Point-To-Point Flight of an All-Electric Helicopter” – originally published on November 4, 2022.

magniX Powers First Point-To-Point Flight of an All-Electric Helicopter

Flight of Battery-Powered Robinson 44 Helicopter Accelerates Path to Sustainable Delivery of Life-Saving Organs

EVERETT, Wash., Nov. 4, 2022 /PRNewswire/ — magniX, a manufacturer of electric propulsion solutions for aviation, is pleased to have powered the first fully-electric helicopter flight between airfields, in partnership with Tier 1 Engineering. The modified electric Robinson 44 (eR44) helicopter powered with a magniX magni250 electric propulsion unit (EPU) made its historic journey from Jacqueline Cochran Regional Airport to Palm Springs International Airport, arriving on 29 October 2022 at 11:00am PST, in a flight that lasted approximately 20 minutes.

Tier 1 Engineering is developing the magniX-powered eR44 for Lung Biotechnology PBC, a subsidiary of United Therapeutics Corporation, a biotechnology company dedicated to addressing the severe shortage of transplantable organs in the U.S. The magniX EPU was retrofitted into the helicopter together with a battery system developed by Tier 1 Engineering, specialists in the design and development of electric aircraft. The eR44 is designed to deliver human and manufactured organs for transplant with zero carbon emissions at the point of use.

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“Building from our first flight of the eR44 helicopter last June, the successfully completed point-to-point flight takes us a step closer to the sustainable transport of life-saving organs,” said Nuno Taborda, CEO of magniX. “magniX is excited to be part of an initiative that will positively affect those in need of urgent medical care. This is only the start of the applications for electric helicopters, which have a bright future as low-cost, carbon-free, reliable alternatives to combustion engine models.”

magniX Celebrates Another Industry First

Since December 2019, magniX has also provided the technology to power a number of first flights, including that of Harbour Air’s “eBeaver”, a Cessna “eCaravan” and, most recently in September 2022, Eviation’s all-electric commuter aircraft, Alice. This point-to-point flight of an electric rotary aircraft represents the latest first for the industry-leading electric solutions company. Tier 1 Engineering is currently working with the FAA on the eR44 project to obtain a Supplemental Type Certificate (STC). Lung Biotechnology PBC plans to acquire a fleet of sustainable aircraft to transport transplant organs.

“We are committed to charting a new path forward for the zero-carbon delivery of life-saving organs,” said Dr. Martine Rothblatt, one of the helicopter’s pilots and CEO of United Therapeutics Corporation. “Saturday’s point-to-point flight proves that the technology necessary for our mission is already here, as we actively work with the FAA to certify the eR44 helicopter.”

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“Together we achieved an incredible outcome for the world’s first airport-to-airport cross-country all-electric helicopter flight,” said Glen Dromgoole, President of Tier 1 Engineering. “magniX has again demonstrated the reliability and power of its electric propulsion units, and we’re proud to continue this journey to create sustainable options for organ donation and, ultimately, help save lives.”

About magniX

Headquartered in Everett, Washington State, U.S., magniX is dedicated to leading an era of environmentally-friendly and sustainable aviation. magniX has developed a family of flight-proven electric propulsion units (EPUs) and is fast maturing its energy storage systems (ESS) for commercial aviation. With high levels of reliability, unparalleled performance and operational practicality, magniX is leading the aviation industry into a sustainable future. magniX is a subsidiary of the Clermont Group, an international business group headquartered in Singapore. For further information, please visit www.magnix.aero.

Contact
FINN Partners for magniX
magniX@finnpartners.com

SOURCE magniX

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Jama Software is always looking for news on our customers that would benefit and inform our industry partners. As such, we’ve curated a series of customer spotlight articles that we found insightful. In this blog post, we share content, sourced from WIRED, about one of our customers, Illumina titled “The Era of Fast, Cheap Genome Sequencing Is Here” – originally published on September 29, 2022, by Emily Mullin.

The Era of Fast, Cheap Genome Sequencing Is Here

Illumina just announced a machine that can crack genomes twice as fast as its current version—and drive the cost down to $200 a pop.

THE HUMAN GENOME is made of more than 6 billion letters, and each person has a unique configuration of As, Cs, Gs, and Ts—the molecular building blocks that make up DNA. Determining the sequence of all those letters used to take vast amounts of money, time, and effort. The Human Genome Project took 13 years and thousands of researchers. The final cost: $2.7 billion.

That 1990 project kicked off the age of genomics, helping scientists unravel genetic drivers of cancer and many inherited diseases while spurring the development of at-home DNA tests, among other advances. Next, researchers started sequencing more genomes: from animals, plants, bacteria, and viruses. Ten years ago, it cost about $10,000 for researchers to sequence a human genome. A few years ago, that fell to $1,000. Today, it’s about $600.

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Now, sequencing is about to get even cheaper. At an industry event in San Diego today, genomics behemoth Illumina unveiled what it calls its fastest, most cost-efficient sequencing machines yet, the NovaSeq X series. The company, which controls around 80 percent of the DNA sequencing market globally, believes its new technology will slash the cost to just $200 per human genome while providing a readout at twice the speed. Francis deSouza, Illumina’s CEO, says the more powerful model will be able to sequence 20,000 genomes per year; its current machines can do about 7,500. Illumina will start selling the new machines today and ship them next year.

“As we look to the next decade, we believe we’re entering the era of genomic medicine going mainstream. To do that requires the next generation of sequencers,” deSouza says. “We need price points to keep coming down to make genomic medicine and genomic tests available much more broadly.”

Sequencing has led to genetically targeted drugs, blood tests that can detect cancer early, and diagnoses for people with rare diseases who have long sought answers. We can also thank sequencing for the Covid-19 vaccines, which scientists started developing in January 2020 as soon as the first blueprint of the virus’s genome was produced. In research labs, the technology has become essential for better understanding pathogens and human evolution. But it still isn’t ubiquitous in medicine. That’s in part because of the price tag. While it costs around $600 for scientists to perform sequencing, clinical interpretation and genetic counseling can drive the price to a few thousand dollars for patients—and insurance doesn’t always cover it.

Another reason is that for healthy people, there’s not yet enough evidence of benefits to prove that genome sequencing will be worth the cost. Currently, the test is mostly limited to people with certain cancers or undiagnosed illnesses—although in two recent studies, around 12 to 15 percent of healthy people whose genomes were sequenced ended up having a genetic variation that showed they had an elevated risk of a treatable or preventable disease, indicating that sequencing may provide an early warning.

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For now, researchers—not patients—will likely benefit most from cheap sequencing. “We’ve been waiting for this for a long time,” says Stacey Gabriel, chief genomics officer at the Broad Institute of MIT and Harvard, of the new improvements. “With greatly reduced costs and greatly increased speed of sequencing, we can sequence way more samples.” Gabriel is not affiliated with Illumina, but the Broad Institute is something of an Illumina power user. The institute has 32 of the company’s existing machines and has sequenced more than 486,000 genomes since it was established in 2004.

Gabriel says there are a number of ways that researchers will be able to apply added sequencing power. One is to increase the diversity of genomic datasets, given that the vast majority of DNA data has come from people of European descent. That’s a problem for medicine, because different populations might have different disease-causing genetic variations that are more or less prevalent. “There’s really an incomplete picture and a hampered ability to translate and apply those learnings to the full population diversity in the world,” Gabriel says.

Another is to boost the size of genetic datasets. In the early 2000s, when the Broad Institute started a project to search for genes related to schizophrenia, researchers had 10,000 genomes from people with the condition, which didn’t yield many insights, Gabriel says. Now, they have amassed more than 150,000.

Comparing those genomes to those of people without schizophrenia has allowed investigators to uncover multiple genes that have a profound impact on a person’s risk of developing it. By being able to sequence more genomes faster and more cheaply, Gabriel says they’ll be able to find additional genes that have a more subtle effect on the condition. “Once you have bigger data, the signal becomes clearer,” she says.

“This is the kind of thing that shakes up everything you’re working on,” agrees Jeremy Schmutz, a faculty investigator at HudsonAlpha Institute for Biotechnology, of new sequencing technology. “This reduction in sequencing cost allows you to scale up and do more of those large research studies.” For Schmutz, who studies plants, cheaper sequencing will allow him to generate more reference genomes to better study how genetics influence a plant’s physical characteristics, or phenotype. Large genomic studies can help improve agriculture by accelerating the breeding of certain desirable crops, he says.

Illumina’s sequencers use a method called “sequencing by synthesis” to decipher DNA. This process first requires that DNA strands, which are usually in double-helix form, be split into single strands. The DNA is then broken into short fragments that are spread onto a flow cell—a glass surface about the size of a smartphone. When a flow cell is loaded into the sequencer, the machine attaches color-coded fluorescent tags to each base: A, C, G, and T. For instance, blue might correspond to the letter A. Each of the DNA fragments gets copied one base at a time, and a matching strand of DNA is gradually made, or synthesized. A laser scans the bases one by one while a camera records the color coding for each letter. The process is repeated until every fragment is sequenced.

For its latest machines, Illumina invented denser flow cells to increase data yield and new chemical reagents, which enable faster reads of bases. “The molecules in that sequencing chemistry are much stronger. They can resist heat, they can resist water, and because they’re so much tougher, we can subject them to more laser power and can scan them faster. That’s the heart of the engine that allows us to get so much more data faster and at lower costs,” says Alex Aravanis, Illumina’s chief technology officer.

That said, while the cost per genome is dropping, for now, the startup cost for a machine itself is steep. Illumina’s new system will cost around $1 million, about the same as its existing machines. The high price tag is a key reason they’re not yet common in smaller labs and hospitals, or in rural regions.

Another is that they also require experts to run the machines and process the data. But Illumina’s sequencers are completely automated and produce a report comparing each sample against a reference genome. Aravanis says this automation could democratize sequencing, so that facilities without large teams of scientists and engineers can run the machines with few resources.

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Illumina isn’t the only company promising cheaper, faster sequencing. While the San Diego-based company currently dominates the marketplace, some of the patents protecting its technology expire this year, opening the door for more competition. Ultima Genomics of Newark, California, emerged from stealth mode earlier this year promising a $100 genome with its new sequencing machine, which it will begin selling in 2023. Meanwhile, a Chinese company, MGI, began selling its sequencers in the United States this summer. Element Biosciences and Singular Genomics, both based in San Diego, have also developed smaller, benchtop sequencing machines that could shake up the marketplace.

Ultima’s machine design has replaced the traditional flow cell with a round silicon wafer just under seven inches in diameter. Josh Lauer, the company’s chief commercial officer, says the disc is cheaper to manufacture and has a bigger surface area than a flow cell, allowing more DNA to be read at once. Because the disc rotates like a record under a camera instead of moving back and forth like flow cells do, Lauer says it requires smaller volumes of reagents and speeds up imaging. “We think this will enable scientists and clinicians to do more breadth, depth and frequency of genome sequencing,” he says. “Instead of just looking at tiny parts of the genome, we want to look at the whole genome.”

Ultima’s machine isn’t widely available yet, and the company hasn’t released the price, though Lauer says it will be comparable to other sequencers on the market.

The increased competition could be a boon to the genomics field, but research is often slow to translate to health improvements in real people. It will likely take time before patients see a direct benefit from cheaper sequencing. “We’re at the very, very beginning,” deSouza says.

The post The Era of Fast, Cheap Genome Sequencing Is Here appeared first on Jama Software.

Jama Software is always on the lookout for news on our customers that would benefit and inform our industry partners. As such, we’ve curated a series of customer spotlight articles that we found insightful. In this blog post, we share content, sourced from Mass Device, about one of our customers, Surgalign titled “FDA Clears Surgalign’s Cortera Spinal Fixation System” – which was originally published on August 24, 2022, by Sean Whooley.

FDA Clears Surgalign’s Cortera Spinal Fixation System

Surgalign (Nasdaq:SRGA) has announced that it received FDA 510(k) clearance for its Cortera spinal fixation system.

Deerfield, Illinois-based Surgalign said in a news release that the new flagship Cortera product represents a key product portfolio piece. Surgalign officials see Cotera driving the company’s future growth. It could ensure market gains in the posterior fixation market.

“The Cortera system is a testament to the spine engineering talent and expertise we’ve assembled in very short order, as we moved from zero engineers in the United States following the RTI divestiture two years ago, to approximately 30 today,” said Terry Rich, president and CEO of Surgalign. “Thanks to our team and incredible surgeon partners, we progressed from company inception to FDA 510(k) clearance with a very polished system in approximately 16 months. We are excited with the prospects the Cortera system brings to Surgalign, and those around the world who rely on our technology to drive better patient outcomes.”

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More about Cotera

Cortera, a 5.5/6mm rod pedicle screw system, offers both open and minimally invasive surgery (MIS) modules, plus a feature-rich screw design with a comparatively low profile and newly designed locking mechanism.

Surgalign designed Cortera to maximize adoption in the spine market, both today and in the future with evolving techniques and technologies. The company added that Cortera demonstrates the ways in which spinal implants will be deployed with technologies like its own HOLO Portal surgical guidance platform.

The company plans to integrate Cortera with HOLO Portal to create what it labeled “an unrivaled user experience for pedicle screw navigation.” Surgalign also has plans for additional implants and instruments to add to the system over the next few years to expand applications into a majority of posterior fixation spinal procedures.

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Surgalign will offer Cortera in a limited market release, which it expects to positively contribute to its 2022 fourth-quarter results and in the coming years.

“The system is hands down the most precise, elegant and comprehensive screw that currently exists in my opinion,” said Dr. Jeremy Smith, chief of spine, Hoag Orthopedic Institute. “I find the system has an evolved sophistication that provides a high-quality user experience and enhanced clinical performance in challenging pathologies.”

Are you a Jama Software customer looking to fill open positions at your organization with prospects who have Jama Connect experience? We’d love to help! Tag us on LinkedIn (@jamasoftware) with your job posting and we’ll share it!

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Founded in 2017 in Los Angeles, California, Auto Motive Power (AMP) has been dedicated to the evolution of e-mobility. With innovative, industry-leading software and hardware, AMP is the world leader in connected battery management, charging, and cloud technology that empowers electric mobility.

The market for electric vehicles is growing at an exponential rate — and not just cars — scooters, airplanes, drones, helicopter markets are all moving toward electrification. As this demand increases, companies like Auto Motive Power (AMP) are tasked with designing, building and monitoring batteries and charging solutions that can withstand this transition away from fossil fuels.

Batteries aren’t cheap, either. It’s estimated that a battery in an electric vehicle can cost as much as 30-40% of the total cost. And given this great expense, companies like AMP are being challenged to find a way to bring down the cost — and AMP is leading the charge.

As an innovator and leader in the battery management industry, AMP is refusing to work within the confines of traditional approaches and instead designing for the needs of today and tomorrow.

After Initially Selecting Intland Codebeamer, AMP Reevaluates and Moves to Jama Connect

As part of their innovative approach to developing vehicle subcomponents, the AMP team began the search for a modern requirements management solution that could help them address the following challenges and objectives:

• Getting users up and running quickly to support their pace of growth
• Managing unique requirement IDs across multiple projects
• Maintaining traceability as things change
• Enforcing efficient processes and workflows in development

Initially, as a new startup, the AMP team was using Atlassian Confluence and Microsoft Word for requirements management. But as the team grew and their processes matured, it became clear that in order to continue pushing the boundaries of innovation, the team needed to move away from static requirements trapped in disparate documents and move towards a modern requirements management platform that enables Living Requirements™ which create a common thread through all downstream activity

“It’s so important to implement a proper requirements management process and solution as part of the DNA of a startup,” said Jana Fernando, Vice President of Technology at AMP. “Making great products starts with having good product definition – and requirements are a prerequisite to that. Having a good RM solution and process means that all stakeholders agree from the very beginning.”

After briefly evaluating IBM DOORS and Siemens Polarion, the team focused on Intland codebeamber for their application lifecycle management (ALM) tool. After just a short 2-3 weeks, the team realized it was, in fact, not the right tool for them and so continued in their search for a requirements management solution that would better meet their needs.

“It’s so important to implement a proper requirements management process and solution as part of the DNA of a startup… Making great products starts with having good product definition—and requirements are a prerequisite to that. Having a good RM solution and process means that all stakeholders agree from the very beginning.” – Jana F, VP of Technology, AMP 

Why Jama Connect Was Chosen Over Other RM Tools

After the trials and limitations experienced with other solutions, AMP’s search for the right modern requirements management platform led the team to select Jama Connect for the following qualities:

• Proven performance and industry credibility
• Powerful yet easy-to-use platform
• Quick implementation
• Premium customer support and industry-specific knowledge

To see how the team is now leveraging Jama Connect and the great results they’ve already seen, read the full customer story here.

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