Medical Device Directory

"Reverse" FDA Compliance

A free white paper by apartis Information Management

Retroactive development of approval documents apartis produced the FDA-approval documentation in accordance with 510(k) and 21CFR, part 11 for medical equipment software that had been developed previously. We developed and executed missing software validation test cases and created a trace matrix and complete software design history file. This enabled the manufacturer to launch their hardware and software on the American market.

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