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21 CFR 820 & FDA QMSR Supplier Control Guide 2026

ALT TEXT 21 CFR 820 and FDA QMSR supplier control guide showing the qualification gap FDA inspectors find during medical device inspections.

FDA QMSR amended 21 CFR Part 820 on 2 February 2026. The purchasing controls that sat in 21 CFR 820.50 now come from ISO 13485 clause 7.4 — with an explicit ongoing monitoring obligation that a one-time supplier qualification cannot satisfy. This guide covers what changed, the six evidence elements an FDA inspection asks for, and a 90-day implementation plan to close the monitoring gap.

Healthcare Vendor Risk Management: HIPAA, FDA & ESG Guide 2026

Healthcare Vendor Risk Management

Healthcare vendor risk management covers HIPAA BAA obligations, FDA 21 CFR supplier qualification, ESG duties and the 2025 HIPAA Security Rule NPRM. This guide maps all regulatory obligations, the Change Healthcare lessons, and what questionnaire-only programmes structurally miss.