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At the end of the day, the requirement simply (or in your case not simply) attempts to ensure that designs are looked at from various perspectives to ensure all potential risk factors are either identified and understood or mitigated. Remember, the FDA is trying to look out for the public not trying to control how any organization runs their individual business'.
By having only those who have been "intimately" involved in the development of the design introduces an additional risk factor - they may have overlooked something.
Good luck with that management team. You will have your challenges.
By having only those who have been "intimately" involved in the development of the design introduces an additional risk factor - they may have overlooked something.
Good luck with that management team. You will have your challenges.