Good Manufacturing Practice (cGMP) | MDV-Solve
Good Manufacturing Practice (cGMP)
For companies targeting the US market, compliance with 21 CFR Part 820 (Quality System Regulation) is essential.
cGMP services:
- Gap analysis against 21 CFR 820
- FDA inspection readiness (Mock Audit)
- QSR training
- Corrective and Preventive Action (CAPA) system
- Complaint handling system
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Establishment and implementation of PMS to review experience gained from devices in the post-production phase.
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