1000980 Speaker Data Sheet, Background
The Master Validation Plan (MVP) is a critical document that outlines the overall approach and strategies for validating a medical device product or process. The Global Harmonization Task Force (GHTF) published guidance in 2004 to help medical device manufacturers develop a comprehensive MVP that meets international regulatory requirements.
The MVP is a comprehensive and dynamic document that provides an overview of the validation activities required throughout the entire product lifecycle. It covers the product design, development, manufacturing, and post-market surveillance phases. The MVP outlines the validation approach, the roles and responsibilities of the team members involved in the validation process, and the specific validation activities required.