Tiny Tentacles of Risk

The FDA’s new Quality Management System Regulation (QMSR), set to replace the longstanding Quality System Regulation (QSR) in 2026, is a seismic shift for MedTech companies. It aligns FDA requirements with ISO 13485:2016 and underscores the importance of ISO 14971:2019, reinforcing a risk-based approach to quality management. But beyond the technical updates, the QMSR sends a clear message: risk management isn’t just about compliance—it’s about culture.

Enzyme’s March 4, 2025 post “Tiny Tentacles of Risk” highlights this shift and features insights from Christie Johnson, co-founder at Prodct Studio.

Christie emphasizes that risk management shouldn’t be a standalone function—it needs to be deeply woven into every aspect of a company’s operations, from product development to post-market activities.