Open Daily: 10am - 10pm | Alley door 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

Open Daily: 10am - 10pm | Alley-side Pickup: 10am - 7pm
3038 Hennepin Ave Minneapolis, MN
612-822-4611
FDA Quality System Regulation for Medical Devices (21 CFR Part 820): A Practitioner's Guide to Management Controls (sections 820.20 Management Respons

FDA Quality System Regulation for Medical Devices (21 CFR Part 820): A Practitioner's Guide to Management Controls (sections 820.20 Management Respons

Daugherty, D. G.

Paperback

Business General

ISBN10: 1522840249
ISBN13: 9781522840244
Publisher: Createspace
Published: Dec 19 2015
Pages: 58
Weight: 0.20
Height: 0.12 Width: 6.00 Depth: 9.00
Language: English
The Practitioner's Guide to Management Controls was written to provide a simple, single source of information for United States Food and Drug Administration's (FDA) requirements for Management Controls as described in 21 CFR Part 820 Quality System Regulation (QS Regulation) for Medical Devices. Management Controls include sections 820.20 Management Responsibility, 820.22 Quality Audit, and 820.25 Personnel of this medical device regulation. The Practitioner's Guide to Management Controls is written for the practitioner to use as a tool to help develop management controls prospectively for a new quality system or to perform gap assessments between existing management controls in a quality system against the FDA requirements and expectations provided in this book.

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