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This thread is carried over and continued in the Current Elsmar Cove Forums |
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This thread is carried over and continued in the Current Elsmar Cove Forums |
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 The Old Elsmar Cove Forums
 FDA and Medical Devices
 War Stories
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Don Winton Forum Contributor Posts: 498 |
posted 14 September 1998 09:59 PM
   
I am interseted in experiences by companies that have undergone an FDA inspection since the new QSR became in effect I understand that Design Controls are a concentration point, but what else? I have experienced DCAS (government AS%&*@)*) audits in the past, but the FDA inspectors are new to me. I am confident my system is compliant, but with subjective assessors, you can never tell. Any comments appreciated. Best Regards, IP: Logged |
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