Medical Device Non-Product Software Validation 101
A step-by-step guide on how to plan, assess risk, write protocols, and conduct tests needed to validate non-product software (NPS) used by medical device manufacturers.
Includes an overview on what non-product software is and why it should be validated; how to create an NPS inventory; how to assess off-the-shelf (OTS) software; and how to create an NPS traceability matrix.