Great questions.  Much needs to be said here regarding this robust and challenging topic for which superficial answers can be risky.  I'll apologize in advance for my lengthy narrative.   Remember that for practical intents and purposes , 21 CFR Part 806 (Medical Devices; Reports of Corrections and Removals ) is inseparable from, and integrated ...

Inside the Bubble - The Cardio Club The Cardio Club was out in full force this year, sigh.  It seemed to be totally in control of MDIC's early feasibility study project, which has been struggling for four years now to address a national emergency, the wholesale departure of early feasibility studies from the US.  Whether they fled by plane, train, ...

If you search the forum for "third party," you will find a discussion of this topic last May that may be helpful. ------------------------------ Julie Omohundro, ex-RAC (US, GS), still an MBA Principal Consultant Class Three, LLC Mebane, North Carolina, USA 919-544-3366 (T) 434-964-1614 (C) julie@class3devices.com ------------------------------

Is a full paper copy and company letterhead cover memo with wet signature required for a Q-Sub Supplement? ------------------------------ Robert Wilkinson President Port Barrington IL United States ------------------------------

LOL, I guess I was thinking "third party," because usually one party in this conversation is me, and the other is the design engineer.  FDA is nowhere to be found. Certainly, if everyone agrees it makes more sense to conform to the recognized standard, that's fine.  More broadly, if you are the design engineer, it's your call as to what test you do ...