Medical Devices
| GMP Medical Device Master Reference Guide |
| 21 CFR 820 - Quality System Regulations |
| Medical Device Quality Systems Manual with 11, 210/211, 820 and QSR Audit Checklist |
| In Vitro Diagnostics Master Handbook |
| Drug & Device GMP Desk Reference Set |
| Updated 2024 - 21 CFR 11, 50, 54, 56, 807, 812, 814, 820, 510K & PMA - Medical Device Combination |
| 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 |
| Updated 2024 - 21 CFR 812 - Investigational Device Exemptions |
| 21 CFR 814 - Premarket Approval of Medical Device |
| 21 CFR 820 - Quality System Regulations-SPANISH |
| Electronic Systems Master Handbook 1 |
| US and EU GMPs with ICH Q7, Q8(R2), Q9(R1), 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 820 and QSR Audit Checklist |
| US, EU and Canadian Medical Device Combination |
| US, EU and Japanese GMPs |
| Medical Device Quality Systems Manual with 11, 820, QSR Audit Checklist, 7382.845 with QSIT |
| EU Medical Device Regulation 2017-745 |
| Canadian - SOR98-282 Medical Devices Regulations |
| In Vitro Diagnostics 2017/746 Medical Devices |
| 21 CFR 4 - Regulation of Combination Products |
| 503B Compounding Master Guide |
| 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 |
| 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 |
| GMP Manufacturing Handbook |
| GMP Boot Camp Training Certificate and GMP Handbook |
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- Guaranteed Lowest Price
- Quantity Discounts Available
- Always Current, Up-To-Date
- Company Logos Available
- Special Customizations
- Pocket-sized 3.75" x 6.25"
- Prep for FDA & Client Audits
- Employee Training & Reference
- Promotional "giveaways"
- Tradeshows and meetings
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