Summary of Design Verification and Validation Documents. This section should summarize or reference or contain design verification and design validation data to the extent appropriate to the complexity and risk class of the device: Such documentation should typically include: • declarations/certificates of conformity to the “recognized” standards listed as applied by the product owner; and/or • summaries or reports of tests and evaluations based on other standards, manufacturer methods and tests, or alternative ways of demonstrating compliance. EXAMPLE: The completed Table of Conformity to the Essential Principles that a recognized test standard was used as part of the method to demonstrate conformity to one Essential Principle.
