Medical Device Industry Handbooks
| 21 CFR 11, 50, 54, 56, 807, 812, 814, 820, 510K & PMA - Medical Device Combination - Includes the June 24th, 2011 Changes |
| 21 CFR 50 - Protection of Human Subjects - Includes the June 24th, 2011 Changes |
| 21 CFR 54 - Financial Disclosure by Clinical Investigators |
| 21 CFR 56 - Institutional Review Boards |
| 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 - Est. Reg. and Device Listing for Manu... |
| 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 - Includes June 1, 2011 Changes |
| 21 CFR 820 - Quality System Regulations |
| 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 |
| Medical Device QSIT Manual with 11, 803, 806, 820 and 821 |
| 21 CFR 820 with Medical Device QSIT Manual |
| US, EU and Canadian Medical Device Combination |
| Audit Fee US |
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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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