Traceability of Design Outputs to Design Inputs a Key Task for MDSAP [Video]

Audit Task 7 is to review medical device specifications to confirm that design and development outputs are traceable to and satisfy design input requirements.

Identification

In addition, verify that the design and development outputs essential for the proper functioning of the medical device have been identified.

Outputs include, but are not limited to:

  • Device specifications
  • Specifications for the manufacturing process
  • Specifications for the sterilization process (if applicable)
  • The quality assurance testing
  • Device labeling and packaging

See entire article: