Wanna Play In The Medical Device Industry?

Then know and practice the expected behaviors!

I received a call earlier this week from a contract manufacturer asking me about a master validation plan (MVP). A medical device customer of theirs performed a supplier audit and asked for their MVP. The company didn’t have one and doesn’t know what a MVP is. Terms like IQ, OQ, and PQ are foreign to the company.

Don’t try to play the medical device “game” without understanding and following the rules. If you don’t understand the rules, ask someone who does. Admit you may not know what you don’t know.