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The Regulation shall apply to in vitro diagnostic medical devices and their accessories
All of the US Drug GMP Regulation
Checklist for GCP Systems Gap Analysis
21 CFR Parts 210/211 (use current title)
Medical Device Quality Systems Manual with 11, 210/211, 820 and QMSR Audit Checklist 11 The Regulation shall apply toUS FDA Title 21 CFR Parts Part 11 Electronic Records Electronic Signatures (ERES) with Scope and Application Part 210 211 cGMP in Manufacturing, Processing, Packaging or Holding of Drugs and Finished Pharmaceuticals Part 820 Quality Management System Regulations (QMSR) 2026 The Auditing Group's 21 CFR Part 820 QMSR Audit Check List with correlations to 21 CFR Part 820, ISO 13485 Medical Device Quality Systems Manual Note: Does not include ISO 13485,
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