Open Daily: 10am - 10pm | Alley door pickup 10am - 7pm 3038 Hennepin Ave Minneapolis, MN
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  • Open Daily: 10am - 10pm
    Alley-side Pickup: 10am - 7pm

    3038 Hennepin Ave Minneapolis, MN
    612-822-4611

Open Daily: 10am - 10pm | Alley-side Pickup: 10am - 7pm
3038 Hennepin Ave Minneapolis, MN
612-822-4611
Devine Guidance for Managing Key Attributes of a FDA-Compliant Quality Management System: 21 CFR, Part 820 Compliance

Devine Guidance for Managing Key Attributes of a FDA-Compliant Quality Management System: 21 CFR, Part 820 Compliance

Devine, Christopher Joseph

Paperback

Series: Devine Guidance, Book 5

Medical Reference

ISBN10: 1500209996
ISBN13: 9781500209995
Publisher: Createspace
Published: Jul 9 2014
Pages: 222
Weight: 1.16
Height: 0.47 Width: 8.50 Depth: 11.02
Language: English
The salient purpose of this book is to provide the readers some additional insight into not only entering devices into the US market place but actually keeping them there. Dr. Devine actually loves the US device market place because the FDA regulations are relatively static. Now that doesn't mean the FDA does not adopt and change to an increasingly dynamic medical device environment in the United States. However, it does mean that FDA is careful when implementing changes to regulatory and statutory requirements versus the EU where the directives change just for the sake of change. Another point the author is compelled to make is that once devices are cleared and or approved (depending on regulatory pathway), they will remain available on the US market, providing they remain safe and effective; however, in Europe not so much.

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