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Testing... The FDA considers your "end to end" product testing. Testing starts at Design Verification testing to the requirements specification. Validation testing is conducted on a pre-production unit made with production documentation, production test equipment and conducted by trained production people using formal documentation. Recurring tests (final test)is performed on a sampled basis measuring key parameters.

This testing should be conducted using a certified test device, on a sampled basis. You remove a finished unit from stock and test the performance of the diagnosis or treatment delivered to the patient to verify the performance meets the requirements specification. copyright by Compliance Consultants, Stamford, CT USA, September 2001