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Hi RAPS Community,
I am in need of a company or individual that has experience performing part 11 gap assessment for medical device companies. We are a medical device manufacturer of Class III diagnostic devices that follows US and EU regulations for medical device manufacturing, and CAP/CLIA requirements for on-site use of the devices. If you know of anyone or are one of these individuals, I would be very interested to hear from you.
Thank you in advance for your time.