Hardware Podcasts

130 - QMSR Changes to Traceability/Reporting, Independent Reviewer & Risk Management, Learning New Regulations and MDSAP with Aaron Snyder

Let's Combinate · 3 Apr 2024 · 32m

What this episode covers

Aaron Snyder, VP of Quality Assurance at Allotex and AAMI Faculty member, explains the FDA's Quality Management System Regulation (QMSR) and its incorporation of ISO 13485. He details specific changes to traceability, including the requirement to meet 21 CFR Part 821 (Medical Device Tracking) and Part 830 (UDI) in addition to ISO requirements, and new FDA-specific controls for records, packaging, and labeling. Snyder contrasts FDA inspection techniques, which focus on finding non-compliance through deep dives into complaint and service records, with ISO surveillance audits that verify conformity. He also discusses the impact of QMSR on MDSAP companies, noting that while harmonization simplifies compliance for large firms, smaller US-only companies face more work to adopt the process approach and explicit risk management.

Most relevant to

large enterprises

Topics

Mentioned

Companies
Allotex, Fresenius Kabi, Molnlycke, Waters Corporation, Covidien, Cardinal Health, General Electric
Also
AAMI, Quality Systems Explained, ISO 13485, 21 CFR Part 821, 21 CFR Part 830, UDI, MDSAP, Good to Great, First Break All the Rules

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