US FDA, Canadian and European MDR

US FDA, Canadian and European Medical Device Regulations

• 21 CFR Part 11 Electronic Records; Electronic Signatures
• 21 CFR Part 11 Scope and Application Guidance
• 21 CFR Part 820 - Quality Management System Regulations (QMSR) 2026
• US FDA QSIT
• The Auditing Group's 21 CFR Part 820 QMSR Audit Check List with correlations to 21 CFR Part 820 & ISO 13485
• Health Canada SOR 98-282 Canada Medical Device Regulations
• EU MDR 2017/745 Medical Device Regulations

Note:

Does not include ISO 13485, however, does include the checklist correlations to 820 QMSR.

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