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What We Do?

CE marking and FDA registration of medical devices and IVDs requires design validation and design verification.

Design Validation: Determining that the finished device delivers its intended function correctly and safely.

Design Verification: Ensuring that the component parts of the device have been designed and specified to deliver their intended functions correctly and safely.

Design validation is one of the most important aspects of the design and development process for medical devices. It is at this stage that the medical device manufacturer confirms that the device that was designed is the right product that meets the needs of the user. Successful design validation requires a thorough understanding of the user needs. Some of the questions that need to be answered during design validation.

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Basics of Design Verification Process

Identifying and Preparing
  • Identify the best approach for conducting verification. Define what you will measure and how you will measure it. You’ll also want to consider the required resources, manpower, and tools for successful verification.
Planning
  • Planning for verification occurs throughout the project life cycle. You’ll develop the test plan, which captures critical milestones. The plan must be updated whenever changes are made to design inputs.
Developing
  • Product development begins! It’s conducted using the methodology of choice (Scrum, Waterfall, hybrid, etc.). This part of the process also includes writing, test driving, and approving the test cases that will be used for verification.
Executing
  • Test procedures are executed as planned. Any invalid results are documented and reviewed, and either accepted or logged as defects. Defects in the product are resolved and released, and regression testing is performed. A traceability matrix is created to verify that design inputs identified in the verification test plan have been tested and passed.
Reporting
  • Reporting is performed at the end of each phase of verification. Detailed reports include configuration management and release reports, test results by testing type or product version, and issues found during the verification activity. A design verification traceability report shows test results and coverage for the requirements. Finally, reviews are completed and approved after each design verification activity.