Risk Management as the North Star for Regulatory Decisions Across the Device Lifecycle

Risk management shouldn’t sit in a silo—it's the connective tissue that informs all regulatory decisions from first-in-human to late-stage lifecycle changes. This session shows how to operationalize ISO 14971 thinking so it directly shapes outcomes at each regulatory juncture: IDE approvals and protocol amendments; 510(k)/De Novo/PMA benefit-risk narratives and special controls; labeling and indication expansions supported by real-world evidence; and postmarket actions including MDR/vigilance reports, field corrections/recalls, remediation plans, and warning-letter closeouts.

Drawing on real case patterns from Class II/III hardware, SaMD, and AI/ML products, we map hazards → harms → risk controls to the specific questions regulators must decide (Is the investigation ethically justifiable? Is the residual risk acceptable? Does the label reflect known/unknowns? Is the CAPA plan sufficient?). You’ll see a practical “Regulatory–Risk Alignment Canvas” that links: hazard analysis and FMEAs to IDE risk minimization; premarket submissions based on clinical benefit-risk; postmarket signals (complaints, PMS, RWE) to risk re-evaluation, PCCP/change management, and communication strategy.

Attendees will learn:

•     How to leverage risk analyses to crisp IDE/premarket/postmarket regulatory arguments.

•     Traceability from hazard/risk controls to indication statements and IFU warnings/limitations.

•     Methods to incorporate real-world data into benefit-risk updates and indication expansions