GMP Publications - Code of Federal Regulation Handbooks by the FDA

Medical Device Industry Handbooks

21 CFR 820 - Quality System Regulations
GMP Medical Device Master Reference Guide
Drug & Device GMP Desk Reference Set
21 CFR 11, 50, 54, 56, 807, 812, 814, 820, 510K & PMA - Medical Device Combination
Medical Device QSIT Manual with 11, 803, 806, 820 and 821
21 CFR 801 - Labeling - Medical Device
21 CFR 803 - Medical Device Reporting
21 CFR 806 - Medical Devices; Reports of Corrections and Removal
21 CFR 807 - Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices
21 CFR 809 - In-Vitro Diagnostic Products
21 CFR 810 - Medical Device Recall Authority
21 CFR 812 - Investigational Device Exemptions
21 CFR 814 - Premarket Approval of Medical Device
21 CFR 11, 820 - Electronic Records with Quality Systems Regulations
21 CFR 11, 210/211, 820 - Electronic Records with Drug and Device GMPs
510k and PMA Guidelines
21 CFR 820 with Medical Device QSIT Manual
US, EU and Canadian Medical Device Combination
Medical Device Quality Systems Manual with 11, 820, QSR Audit Checklist, 7382.845 with QSIT
In Vitro Diagnostics 98/79/EC Medical Devices
21 CFR 50 - Protection of Human Subjects
21 CFR 54 - Financial Disclosure by Clinical Investigators
21 CFR 56 - Institutional Review Boards
21 CFR 11, 820 QSR and 830 UDI
21 CFR 3, 4, 11, 210/211, 820, ICH Q7 - Combination Product GMP Master
3 Day On-Site FDA/EU GMP Boot Camp Training Fee - International - 20 free GMP Master Handbooks
21 CFR 4 - cGMP for Combination Products
In Vitro Diagnostics Master Handbook
GMP International Master Reference Guide
Audit - US
Title 21 CFR Parts 1 - End Nine Volume Set
EU Medical Device Directives 2017-745
503B Compounding and Packaging
2 Day Drug GMP Bootcamp - US - 20 free GMP Master Handbooks
example: 211, ISBN, Drug, GMP, Etc. - Press Enter
Mix and Match End of Year Special New Books Featured Publication GMP Boot Camp GCP Device GMP GCP-DRUG Featured Publication
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