21 CFR 11, 50, 54, 56, 807, 812, 814, 820, 510K & PMA - Medical Device Combination
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GMP Medical Device Master Reference Guide
Over 900 Pages of Guidance and Regulations for the Medical Device Industry Medical Device Master Manual
US FDA Title 21 CFR Parts:
- Part 11 - Electronic Records/Electronic Signatures (ERES)
- Part 801 - Labeling - Medical Device
- Part 803 - Medical Device Reporting
- Part 806 - Reports of Corrections and Removal
- Part 807 - Estab. Reg. and Device Listing for Manuf
- Part 809 - In-Vitro Diagnostic Products
- Part 810 - Medical Device Recall Authority
- Part 812 - Investigational Device Exemptions
- Part 814 - Premarket Approval of Medical Device
- Part 820 - Quality Systems Regulations
- Part 821 - Medical Device Tracking Requirements
- Part 830 - Unique Device Identification
Guidance:
- Added - 820 QSR Checklist with ISO 13485 Reference
- Medical Device QSIT Manual
- PMA Premarket Approval and 510 (k) Guidance
- Inspection of Medical Device Manufacturers 7382.845
- EU 2017/745 Medical Device Regulation
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