Medical device design control template

Medical device design control template


  • Watch Now: Move From a Documents-Based Design Control and Risk Management in Medical Device
  • Does Your Medical Device Need Design Controls? Here’s What You Need to Know.
  • The Medical Device Blog
  • Design and Development Plan Template (Medical Device per ISO 13485 and 21 CFR 820) Free
  • Facilitate the Medical Device Design Controls with Modern Requirements
  • Requirements, Risk, and Test Management for Medical Device Developers
  • Watch Now: Move From a Documents-Based Design Control and Risk Management in Medical Device

    Download it here. Coding changes. Materials substitution. Design refinements. UX improvements. Manufacturing changes. Medical devices, like all products and software, are constantly evolving.

    Yet, due to the nature of medical devices and their impact on personal health and safety, the entire product life cycle of a device must be carefully documented. Design controls apply to the design of the product and associated manufacturing processes.

    The US FDA has identified lack of design controls as one of the major causes of device recalls, and therefore they want you to pay specific attention to the following: Documenting design procedures and development planning. Identifying design input requirements and developing outputs. Verifying that those outputs meet design inputs. Controlling design changes and reviewing design results.

    Conducting risk analyses and design reviews. Transferring the design to production. We will talk about each of these things later. Think of design control as a framework While design control is not required for all medical devices, it applies to nearly every medium- and high-risk device.

    Likewise, ISO mandates design controls. We will talk more about the specific requirements of design controls, but it is important to remember that design control requirements are a framework and not a prescriptive solution. It never ends. Design control does not, however, apply to the ideation stage of medical device development. However, you do need to start creating a plan once you have decided that a specific design will be developed. To assist regulators, you should document the flow of the design process so it is very clear where research is ending and development of the chosen design is beginning.

    Even if a device has been in the marketplace for years, design control is never really finished. Both large and small changes to a device or associated manufacturing process must be evaluated for their impact on product performance, safety, and use. The overall design control model Source: US FDA Setting the stage with design reviews Design reviews are an important part of the overall design process. The objective is to establish a process to make sure the design you created the output meets your design requirements the input.

    A design review provides a mechanism that confirms the design is ready to move to the next stage of the process. Although it is technically focused, a design review is not limited to only the design of the product.

    The resulting analysis provides feedback for the design team. Both FDA and ISO require you to conduct and document these formal reviews on a regular basis at appropriate stages during the development process.

    The documented results become a part of the DHF. Those reviews must include representatives from all functions involved in the design process and any other specialist personnel. FDA also requires you to add an independent reviewer without direct responsibility for the design stage being assessed. The number and types of reviews are project-dependent, so define them in the plan. Review frequency will be impacted by the size and scope of the project and the product development life cycle.

    At minimum, two design reviews should be held — one at the beginning during the design inputs review process and another at the end during the design transfer phase. Medical device design control planning Before you can control your product design, you need a plan for doing so. It also provides a basis for measuring conformance to quality system objectives. This means you must: Establish documented procedures for design and development.

    Identify the design and development stages and the development life-cycle model. Identify the activities of development and the deliverables that come from them.

    Define responsibilities and authorities for executing the activities. Review, update, and approve plans as design and development evolve. The form and organization of the planning documents are less important than their content and should be customized for each company. Remember that as development progresses, the planning documents should be updated. Change and configuration management Product development is inherently an evolutionary process.

    While change is a healthy and necessary part of product development, quality can only be maintained if those changes are controlled and documented. As such, a key component of design control involves establishing procedures to identify, document, review, verify, validate, and approve design changes before they are implemented. You are not expected to maintain records of all changes proposed during the very early stages of the design process. However, all design changes made after the first design review must be documented.

    These records create a history of the evolution of the design, which can be useful for failure investigation and for facilitating the design of future similar products. Such records can also prevent repeat errors and the development of unsafe or ineffective designs.

    Examples of design changes that must be controlled include: Changes made to the device itself or software Changes in design inputs Performance changes or changes resulting from complaints Changes that influence previous approved design verification and validation New design criteria added to existing documentation as project milestones are reached While you are required to document changes, the extent of your evaluation and documentation should be in direct proportion to the significance of the change and its effect on other parts and product in process or already delivered.

    Want to learn more about design control for medical devices? Keep reading. Our second blog post in this series gets into the details surrounding design inputs, outputs, verification, and validation. Also, while reading this series is a great start, you can take your knowledge of design controls to the next level in our intensive design control training class.

    Our team is here to help. Call 1.

    Does Your Medical Device Need Design Controls? Here’s What You Need to Know.

    Start Free Trial Facilitate the Medical Device Design Controls with Modern Requirements Constant development and innovation in medical devices is critical to ensure personal health and safety. Due to the nature of medical devices and the strict regulatory compliance needs, requirements management is deeply related to the success of any type of medical device.

    In this article, we will explore how to manage the medical device design controls more efficiently by using Modern Requirements. Understanding Medical Device Design Controls Design Controls represent a mandated approach to show many layers of documentation, the purpose of which is to ensure that medical devices meet user needs, intended uses, and specified safety requirements. The range of medical devices regulated is huge, including pacemakers, cardiovascular stents, respiratory ventilators, and relatively simple devices such as patient scales and elastic bandages.

    Likewise, ISO mandates design controls. How could Modern Requirements help? Modern Requirements is a world-class requirements management tool and has been a market leader for over 10 years. 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. 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? 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.

    Such records can also prevent repeat errors for the design of future similar products. As a pacemaker manufacturer, you are working on finalizing the design requirements for a new pacemaker model. Imagine how many downstream Work Items needed to be reviewed, modified, and documented? First, the Impact Analysis feature allows you to manage the impact of change by viewing all suspect requirements linked to the changing requirement. Doing so enables you to estimate the impact of each change, and create tasks to complete the work — vs.

    This allows your team to easily identify if a requirement that matches a certain set of criteria which you specify changes and reminds you to examine associated requirements once before proceeding to the next step. The documented results become a part of the DHF. FDA also requires you to add an independent reviewer without direct responsibility for the design stage being assessed. The Review module of Modern Requirements4DevOps provides access for even external reviewers and approvers to review, comment, and approve your design requirements.

    In our platform, you can connect e-signatures to selected reviews to achieve full 21 CFR Part 11 compliance. With just a one-click effort, all historical review results could be generated in an Audit report in PDF or Word format. Trace Analysis How to keep track of user needs, hundreds of specifications, and their associated verification and validation status?

    This is the most asked questions we received from our clients producing Medical Devices. We offer two types of requirement Traceability Matrices. Intersecting Matrix. A 2X2 cross- reference chart between any two types of Work Items. Test coverage is basically a quality check on test cases, and we can increase our test coverage by creating additional useful test cases and omiting unnecessary test cases. Horizontal matrix. This matrix maps Product and Technical Requirements with Test Cases and Defects in a linear format and allows for easy identification of linked requirements by finding the specific Test Case.

    It also helps determine number of tests required, types of tests required, and whether these tests can be automated, done manually, or re-used.

    Once we figure these factors out, we can yield the best possible test case and help provide the overall defect status through logs of defects. Lastly, a Horizontal Traceability Matrix can help estimate the impact of reworking test cases, conducted by a QA team.

    Your Traceability Matrix is always fully configurable and up-to-date. Final Thoughts Meeting regulatory requirements is often a gnarly and cumbersome process. If managed properly, your medical device design control process can be efficient, accurate, and pleasant. By implementing Modern Requirements4DevOps, you can simplify compliance by gathering all key pieces of information into a single location and leveraging the wisdom we have been accumulating for years to help you take control of your device development processes.

    The Medical Device Blog

    Conducting risk analyses and design reviews. Transferring the design to production. We will talk about each of these things later. Think of design control as a framework While design control is not required for all medical devices, it applies to nearly every medium- and high-risk device. Likewise, ISO mandates design controls.

    We will talk more about the specific requirements of design controls, but it is important to remember that design control requirements are a framework and not a prescriptive solution. It never ends.

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

    Design control does not, however, apply to the ideation stage of medical device development. However, you do need to start creating a plan once you have decided that a specific design will be developed. To assist regulators, you should document the flow of the design process so it is very clear where research is ending and development of the chosen design is beginning.

    Even if a device has been in the marketplace for years, design control is never really finished. Both large and small changes to a device or associated manufacturing process must be evaluated for their impact on product performance, safety, and use.

    The overall design control model Source: US FDA Setting the stage with design reviews Design reviews are an important part of the overall design process. The objective is to establish a process to make sure the design you created the output meets your design requirements the input.

    A design review provides a mechanism that confirms the design is ready to move to the next stage of the process.

    Facilitate the Medical Device Design Controls with Modern Requirements

    Although it is technically focused, a design review is not limited to only the design of the product. The resulting analysis provides feedback for the design team.

    Both FDA and ISO require you to conduct and document these formal reviews on a regular basis at appropriate stages during the development process. The documented results become a part of the DHF. Those reviews must include representatives from all functions involved in the design process and any other specialist personnel. Design Review. At various points in the process, your team must conduct and sign off on formal design reviews. Design reviews give your team the opportunity to evaluate the design requirements and tzz&sub1=chujgwm sure that your product is on track to meet them.

    Design Verification. In this step, your team will test the product in various ways to ensure that it has been developed correctly. In essence, design verification seeks to prove that your device works as intended.

    Design Validation. Design validation is another way of testing your product to see if it works. Design validation is all about user testing. Design Transfer. Design transfer is another way of saying design production. In this phase, which overlaps with design validation, you begin the process of actually producing your medical device. Design Changes. Design Controls apply to the entire lifespan of a medical device, not just the initial development.

    Each of the above Design Controls components must be included in your development process. The most common approach to Design Controls is captured in what is known as a waterfall diagram. It must also make clear the links between the various Design Controls.

    By now it should be clear that Design Controls will touch on every aspect of your product development process. Hazardous risk scoring Still using tools outside your project environment to calculate hazard or risk scores? 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.

    Requirements, Risk, and Test Management for Medical Device Developers

    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.

    Such records can also prevent repeat errors for the design of future similar products. As a pacemaker manufacturer, you are working on finalizing the design requirements for a new pacemaker model. Imagine how many downstream Work Items needed to be reviewed, modified, and documented? First, the Impact Analysis feature allows you to manage the impact of change by viewing all suspect requirements linked to the changing requirement.

    Doing so enables you to estimate the impact of each change, and create tasks to complete the work — vs.


    thoughts on “Medical device design control template

    Leave a Reply

    Your email address will not be published. Required fields are marked *