From Static to Dynamic: Rethinking Risk Management for Connected Medical Devices

Traditional risk management wasn’t built for today’s software-intensive, connected medical devices. With the FDA’s QMSR now in effect, static, document-driven approaches are costing teams twice: in the lab and in the audit room.

Join Sunstone Pilot Consulting and Cognition Corporation for a candid, discussion-style conversation on what dynamic risk management looks like in practice, and why it matters to everyone on the product team.

For Engineering and R&D: Risk shouldn’t be a document you chase at the end. Dynamic, platform-based risk management feeds design decisions as they happen, so teams catch problems earlier, cut rework, and build better products faster.

For Regulatory and Quality: One living source of truth means traceability is already there when the auditor asks. Audits get easier, and QMSR alignment becomes a byproduct of how you work, not a scramble before inspection.

Our panel will dig into:

• Why platform-based approaches are replacing static risk management
• How risk-informed design improves product development outcomes
• What QMSR scrutiny means for your risk files, and how to be ready
• Where engineering and regulatory goals align (and where they collide)

Expect a structured but conversational format with plenty of time for audience Q&A. No slide-reading, just practical insight from people building and evaluating these systems every day.