GMP Publications - Code of Federal Regulation Handbooks by the FDA

Medical Devices

21 CFR 11, 210/211, 606, 820 - Electronic Records with Drug, Blood and Device QSR Industry GMPs
21 CFR 11, 210/211, 820 - Electronic Records with Drug and Device GMPs
21 CFR 11, 210/211, 820, ICH Q7 - Good Manufacturing Practice Handbook
21 CFR 11, 50, 54, 56, 807, 812, 814, 820, 510K & PMA - Medical Device Combination
21 CFR 11, 58, 210/211, 600, 601, 610, 820 - Multi-US GMPs
21 CFR 11, 58, 820 - Electronic Records with GLP and QSR
21 CFR 11, 820 - Electronic Records with Quality Systems Regulations
21 CFR 58, 820 - GLP and QSR
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 820 - Quality System Regulations
21 CFR 820 - Quality System Regulations-SPANISH
Electronic Systems Master Handbook 1
EU and US GMPs with ICH Q7, Q8(R2), Q9, Q10
Medical Device QSIT Manual with 11 and 820
Medical Device QSIT Manual with 11, 803, 806, 820 and 821
Medical Device Quality Systems Manual with 11, 210/211, 820 and QSR Audit Checklist
Medical Device Quality Systems Manual with 820 and QSR Audit Checklist
US, EU and Canadian Medical Device Combination
US, EU and Japanese GMPs
In Vitro Diagnostics 98/79/EC Medical Devices
21 CFR Parts 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
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
example: 211, ISBN, Drug, GMP, Etc. - Press Enter
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