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Re: FDA's Medical Device Quality Systems Manual withdrawn
Hi Ronen,
No worries, and I really appreciate your asking.
The customer is auditing our facilities, and validating our processes now. We have requested for their requirement and was told, "Our standard are FDA's standard", so I was wondering what's FDA Standard even we are ISO 13485 certified hybrid plant.
That's why I mentioned comprehensively is to quickly recapture what is FDA standard which I may have missed, or not doing it right.
Regards,
Sean
Hi,
Not sure what you mean by "comprehensively understand the FDA standards with ISO13485", but if you describe the customer's inquiry we might be able to help.
Cheers,
Ronen.
Not sure what you mean by "comprehensively understand the FDA standards with ISO13485", but if you describe the customer's inquiry we might be able to help.
Cheers,
Ronen.
No worries, and I really appreciate your asking.
The customer is auditing our facilities, and validating our processes now. We have requested for their requirement and was told, "Our standard are FDA's standard", so I was wondering what's FDA Standard even we are ISO 13485 certified hybrid plant.
That's why I mentioned comprehensively is to quickly recapture what is FDA standard which I may have missed, or not doing it right.
Regards,
Sean