A medical device verification and validation program is a comprehensive process that is designed to ensure that a medical device functions as intended and meets all safety and regulatory requirements. The verification and validation process typically includes the following steps:

  1. Define the product requirements
  2. Design the product to meet the requirements
  3. Test the product design against the requirements (verification)
  4. Manufacture the product and test it against the requirements (validation)
  5. Release the product for use in humans

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