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Old 15th December 2011, 07:39 AM
JeantheBigone JeantheBigone is offline
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Question Books for FDA Medical Device Regulatory Affairs?

I'm thinking of getting some references and ask if anyone is familiar with these two books. If so, would you recommend them? Are there other books that are useful?

Medical Product Regulatory Affairs: Pharmaceuticals, Diagnostics, Medical Devices by John J. Tobin

Cost-Contained Regulatory Compliance: For the Pharmaceutical, Biologics, and Medical Device Industries by Sandy Weinberg

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Old 15th December 2011, 08:55 AM
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Ajit Basrur Ajit Basrur is offline
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Re: Books for FDA medical device regulatory affairs?

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In Reply to Parent Post by JeantheBigone View Post

I'm thinking of getting some references and ask if anyone is familiar with these two books. If so, would you recommend them? Are there other books that are useful?

Medical Product Regulatory Affairs: Pharmaceuticals, Diagnostics, Medical Devices by John J. Tobin

Cost-Contained Regulatory Compliance: For the Pharmaceutical, Biologics, and Medical Device Industries by Sandy Weinberg
The book by John Tobin is good. I do not know about Sandy Weinberg.

Another good book is FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics

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Thanks to Ajit Basrur for your informative Post and/or Attachment!
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Old 15th December 2011, 10:20 AM
thelastdon99 thelastdon99 is offline
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I Say... Re: Books for FDA medical device regulatory affairs?

I agree with Ajit on the Tobin book being good. I also recommend

The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices, Second Edition by Amiram Daniel

http://www.amazon.com/Worldwide-Qual.../dp/0873897404

It breaks each part of 21 cfr 820 down for you and provides published guidance on each.
Thanks to thelastdon99 for your informative Post and/or Attachment!
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Old 15th December 2011, 10:22 AM
JeantheBigone JeantheBigone is offline
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Re: Books for FDA medical device regulatory affairs?

Thanks so much. Ajit I have the one that you mention and I do find it very helpful.
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