Medical Device Industry Handbooks
| 21 CFR 820 - Quality System Regulations |
| GMP Medical Device Master Reference Guide |
| Drug & Device GMP Desk Reference Set |
| Updated 2024 - 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 |
| Updated 2024 - 21 CFR 812 - Investigational Device Exemptions |
| 21 CFR 814 - Premarket Approval of Medical Device |
| 510k and PMA Guidelines |
| 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 2017/746 Medical Devices |
| Updated 2024 - 21 CFR 50 - Protection of Human Subjects |
| 21 CFR 54 - Financial Disclosure by Clinical Investigators |
| 21 CFR 56 - Institutional Review Boards |
| 21 CFR 4 - Regulation of Combination Products |
| In Vitro Diagnostics Master Handbook |
| GMP International Master Reference Guide |
| Title 21 CFR Parts 1 - End Nine Volume Set |
| 21 CFR Part 820 QSR and 2026 Updated QMSR 2-February 2024 |
| EU Medical Device Regulation 2017-745 |
| Canadian - SOR98-282 Medical Devices Regulations |
| US FDA, Canadian and European MDR |
| 21 CFR Part 4 Regulations for Combination Devices with 21 CFR Part 820 QSR and 2026 Updated QMSR 2-February 2024 |
| 503B Compounding Master Guide |
| GMP Manufacturing Handbook |
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