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Medical Device Verification and Validation
Verification and validation is the process of determining whether a medical device and its manufacturing process meets design input requirements and ensures that devices conform to defined user needs and intended uses. It answers the questions, "Are you building the right safe and effective device?" and "Are you building it right?" One of the most common reasons that ISO auditors and the FDA issue warning letters is because they notice an inadequate verification and validation—or a complete lack thereof. Successful validations satisfy compliance and regulatory requirements, and they also provide for robust manufacturing processes. The result is increased operational efficiency and reduced costs within an organization. This course reviews regulatory terminology of verification and validation and explores tools that can be used to set-up and implement a robust and cost-effective medical device product and manufacturing process verification and validation program. Topics include:
- Site validation master plan requirements
- Validation of computer systems, facilities, utilities, laboratory instrumentation and manufacturing processes
- Principles of effective medical device product and manufacturing process verification and validation
- Writing effective verification and validation plans, protocols and final reports
- Writing Effective Clinical Trial Plan, Protocol and Report
Skills needed: Knowledge of regulatory compliance for medical devices will be helpful.
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