Medical device design control template


  • Requirements, Risk, and Test Management for Medical Device Developers
  • Implementing an effective Risk Management process
  • Facilitate the Medical Device Design Controls with Modern Requirements
  • Watch Now: Move From a Documents-Based Design Control and Risk Management in Medical Device
  • Design and Development Plan Template (Medical Device per ISO 13485 and 21 CFR 820) Free
  • Understanding Medical Device Design Controls: What, Why, and How
  • Requirements, Risk, and Test Management for Medical Device Developers

    Contact Implementing an effective Risk Management process Identifying, estimating, and evaluating your device risks at the right time will increase the quality and safety of the device and can motivate the project members.

    Furthermore, it adds value by decreasing the project risks and avoiding costly late-stage changes. This article will provide you with some tips on implementing — or improving — your effective Risk Management process.

    There are several aspects of implementing an effective Risk Management process. One thing is to establish a Risk Management process including usable and operational templates so that the process complies with ISO Another thing is to support the organization when working with the Risk Management process. But the foundation for implementing an effective Risk Management process is to have written procedures and operational templates.

    For the tips in this article, we have assumed that establishing and maintaining procedures and templates is the responsibility of the Design Control Specialist and using the templates and understanding and applying the procedures is the responsibility of the Project Manager.

    This article gives you ideas to help you succeed with your Risk Management process by providing some tips for both your procedure and your templates from the perspectives of a Design Control Specialist and a Project Manager. Tip 1 — Allocate the right resources Design Control Specialist If your development procedure is aligned with Design Control, you can tailor your procedure to ensure that Design planning is the first activity to be carried out.

    This ensures that resources, responsibilities, and interfaces to other groups or activities are described and allocated. Project Manager The essential part of a successful and value-adding Risk Management process is due diligence and the involvement of the right competencies. This ensures that Risk Management is used as design input and not rationalizing after the device has been designed and developed.

    Resources should be allocated to Risk Management as successful Risk Management is a team effort and should not be the responsibility of the Risk Manager alone.

    Risk assessments are appropriately carried out in workshops where relevant competences participate. This enables a common understanding and insight in the identified risks and the device. Remember that Risk Management is an iterative process and the Risk Management file shall be updated throughout the project. Tip 2 — Align procedures and templates Design Control Specialist By aligning the steps of your Risk Management procedure and the columns in your templates you will ensure that your procedure and templates are operational.

    You can also consider having your procedure illustrate exactly where in the template each step is to be filled out. Project Manager If you have questions to a specific column in the template, e. This will enable efficient review and inspection of procedures and records as well as ensure that correct and consistent terminology is used within the organization.

    Project Manager Using the correct and consistent terminology minimizes the risk of miscommunication within the project.

    Implementing an effective Risk Management process

    By Jama Software August 18, Medical device companies are on the cutting-edge of advancing health care. Along with facing relentless pressures to innovate and release quality products, they also must comply with regulations and standards to remain competitive. And a big part of that is design control and risk management in medical device development. We recently held a webinar specifically designed for product and engineering teams building medical devices , demonstrating how to move beyond the frustrations of disconnected, document-based requirement systems, streamlining your design and development and risk management processes while maintaining compliance with applicable regulations and standards.

    Move from a Documents-Based Design Control and Risk Management in Medical Device If we consider two aspects of your work, the first being the processes and tools that define your methodology and support your work, and the second being the documentation generated to show compliance with applicable regulations and standards, what tends to drive your team?

    Although it is true that both are necessary, you may find that one carries more weight than the other. For many medical device manufacturers, the answer has been to prioritize the documentation needs of the quality system, especially when considering regulated design control and risk management activities. Our assertion here at Jama Software is that having to prioritize the documentation needs over the product definition and development process and tools is unnecessary.

    In fact, many times what feels like a prioritization of the documents over all else, is really just a symptom of using documentation tools like Word or Excel to manage product development activities. What tends to happen is the quality management system requires specific documents as evidence of proper design and development activities and to show alignment with regulatory requirements.

    And working backwards from those quality needs results in the use of documentation tools to support the product development life cycle. This may work for a while, but often does not scale. The problem here is that the opportunity to improve processes and to increase efficiency and quality is not found in the documentation improvements.

    The opportunities to improve are in the product development processes and tools. And this is where teams gained value. The Challenge Medical Device Development Teams Face in Design Control The challenge, as we see it, is that teams are trying to balance the needs of meeting design control regulatory requirements with how they desire to work.

    And I call it specifically this idea of how teams desire to do work, because our customers are, more often than not, looking to modernize and see a lot of opportunities in new solutions and becoming more collaborative, really improving how they work.

    Design control and risk management activities and the resulting required artifacts are, many times, supported by existing document-centric processes and tools. And although they are difficult to work with, sometimes the confidence and the comfort in having them and not changing, outweighs the benefits of modernizing through supporting tools and introducing change.

    However, though, we would argue that this comfort and confidence is really in perception only. Behind that perception is the reality of teams struggling with the need to align to market and user needs, deliver quickly to market, and build efficiencies into how they work together.

    All the while working to produce and maintain the necessary design control and risk related artifacts. The issue is that how teams work, and the documentation needs are being at odds with one another. Beyond team members simply struggling to keep up with the documentation needs and create the trace matrix, there is real risk to quality and gaining clearance, especially as product complexity only increases.

    And while it may seem that the documents that go into submission, as long as they are polished in the end, should continue to be the focus, even more so, as the docs and spreadsheets need to manage more information. There is clearly a tipping point. At some point, the ineffective and inefficient use of tools to manage everything becomes a risk in itself. Things get missed, precious time gets consumed, rework overwhelms innovation.

    Now, this is not to say that compliance related design control and risk documentation is not important. It definitely is important. Especially considering the regulations and requirements behind them. The intention here is not to suggest that the documentation is not significant. The Complexity of Design Control of Medical Device is Real To take just a couple of examples, here you can see that the median number of years to reach the initial k clearance has increased from three and a half years to just over five years.

    That is over a 2, percent increase. And consider this, that chart starts at , and Microsoft Word, which many of the customers I work with are transitioning away from, was launched in You may consider increasing complexity against productivity, or metrics around time to market, or even your organizations willingness to change and to adopt new tools. These might be places you find where the challenge manifests for your teams.

    Balancing the Requirements of the Quality System with Your Approach The shift, we see it, is not to eliminate or downplay the importance of the documentation supporting your regulated, auditable, design control and risk management activities. We see the shift as balancing the requirements of the quality system with your approach to product development. And this balance is found by constructing an approach to how you work, so that the needs of the quality system and the required documentation are actually byproducts of your work, not in themselves defining, or the constraining factor.

    By shifting or balancing, really, the focus toward your product development approach, we suggest that organizations can then look to improve their processes and modernize their tools without negatively impacting or neglecting the regulatory requirements driving documentation today. And the key to making the shift, one that balances product development and documentation needs, is Systems Thinking. And the shift and implementation of Systems Thinking, with it manufacturers can really begin to take advantage of systems engineering principles for developing complex products and find efficiencies in how they work, both cross functionally and in the solutions and tools they use to support their work.

    Watch the full webinar recording to learn more about implementing a design control and risk management approach informed by System Thinking, how Jama Connect for Medical Device Development can help, and more.

    Facilitate the Medical Device Design Controls with Modern Requirements

    With clients such as Philips Healthcare, Siemens Healthineers, Becton Dickinson, and Varian Medical Systems, we keep absorbing suggestions and feedback and improving our capabilities of assisting our clients in medical devices regulatory compliance in each possible way. The system capabilities described below are crucial in helping to ensure that all of the regulatory requirements within your design controls processes are met, resulting in quicker complete compliance, slashed product development cycle times, and faster value delivery.

    Requirements authoring Over the past decade, we have consistanly heard from our clients that using Modern Requirements for requirement authoring is an easy and pleasant process. Every project is unique. There is no universal process template for all projects. With ModernRequirements4DevOps, you decide the requirement Work Item types, their hierarchical relationships, and what fields to include in each Work Item type that best fit your project and team; no matter whther you subscribe to Agile, CMMI, Scrum, or a custom hybrid type of methodology.

    Normally we see over thousands of requirement Work Items in a single medical device design project. You can use the CustomID feature to automatically categorize your requirements and help your team identify and use them more efficiently. A typical Agile based project and its requirement Work Items Physicians, surgeons, technicians, and nurses, whoever you invite to participate in the design process of your new device, now can join the project discussion or even create requirements directly through email without a Modern Requirements license!

    Review our Email Monitor feature to know more about how to join requirements authoring for external stakeholders. How about diagramming? Diagramming is another way to create requirements in your project.

    Watch Now: Move From a Documents-Based Design Control and Risk Management in Medical Device

    You may need a diagram to describe the relationship between Design Controls elements or another diagram to visualize the data flow. With just one click, the system could automatically generate User Stories, Use Cases, and Test Cases simply by extracting information from the diagram you created within our module. With provided stencils and an intuitive positioning guide, let us help you integrate Diagrams fully into your requirements authoring process. The system could detect all possible routes in your diagram and generate requirements accordingly.

    All you need to do is to make a decision to publish them or not. Hazardous risk scoring Still using tools outside your project environment to calculate hazard or risk scores?

    Design and Development Plan Template (Medical Device per ISO 13485 and 21 CFR 820) Free

    Risk scoring is a process of calculating a score which could indicate how severe a risk is, based on associated factors. It is one of the most critical parts of risk and hazard management in medical device compliance. With the help of MatCal and our reporting tools, you can generate a hazard risk report to identify factors that pose a threat to your project. This feature enables you to analyze and evaluate risks of a specific hazard and establish suitable ways to mitigate it. Or implement risk-control measures if the hazard cannot be removed.

    Documenting all user needs, design input, design planning, design output can be overwhelming. Or simply drag and drop some of your existing requirements to any individual document where you need them.

    This feature allows you to access your Work Items in multiple ways, either editing your requirements in the Backlog or Work Items view where you could see all your requirements of the current project, or just focusing on a subset you are working on in a Smart Document view.

    Our Smart Report functionality offers more than just a plain export activity — customized reports are available on-demand. In addition to customizing the display format, you can add static content and your company logo or watermark to a built-in report template and reuse it anytime you want. In Modern Requirements, every change you make to an individual Work Item is captured as a revision of it.

    Compare historical versions of a Work Item to track what has changed Plus, we have a variety of functionalities to keep track of every major and minor change along the road. Plus, being able to compare various baselines to see what has changed helps you manage your product development more efficiently. If a particular product version fails, you need to rollback requirements to a previously working state.

    Modern Requirements4DevOps enables you to manage versions, branch and merge and comply with reporting demands in our Baseline module. Baselining different versions of your design allows you to show the evolution of the design, which can be useful for testing failure investigation. This article gives you ideas to help you succeed with your Risk Management process by providing some tips for both your procedure and your templates from the perspectives of a Design Control Specialist and a Project Manager.

    Understanding Medical Device Design Controls: What, Why, and How

    Tip 1 — Allocate the right resources Design Control Specialist If your development procedure is aligned with Design Control, you can tailor your procedure to ensure that Design planning is the first activity to be carried out. This ensures that resources, responsibilities, and interfaces to other groups or activities are described and allocated.

    Project Manager The essential part of a successful and value-adding Risk Management process is due diligence and the involvement of the right competencies. This ensures that Risk Management is used as design input and not rationalizing after the device has been designed and developed. Resources should be allocated to Risk Management as successful Risk Management is a team effort and should not be the responsibility of the Risk Manager alone. Risk assessments are appropriately carried out in workshops where relevant competences participate.

    This enables a common understanding and insight in the identified risks and the device. Remember that Risk Management is an iterative process and the Risk Management file shall be updated throughout the project.

    Tip 2 — Align procedures and templates Design Control Specialist By aligning the steps of your Risk Management procedure and the columns in your templates you will ensure that your procedure and templates are operational. You can also consider having your procedure illustrate exactly where in the template each step is to be filled out.


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