The New Way to Manage Risk: Functionally Linked, Traceable & Audit-Ready скачать в хорошем качестве

The New Way to Manage Risk: Functionally Linked, Traceable & Audit-Ready

In Episode 4 of our Lunch with Larry series on Design Control, Larry unpacks the real story behind Risk Management in medical device development—why traditional risk matrices aren’t enough, and how to evolve your process into a functionally linked, traceable, and auditable system. This is more than FMEA tables. It’s about connecting your risks to real design inputs, requirements, mitigations, and even test cases—creating an ecosystem where your risk is always traceable and updated as your product evolves. ✅ In this session, you’ll learn: How to connect risk controls to requirements and verifications Why traceability is your best friend in audits and submissions. The role of functions, failure modes, and design outputs in smart risk workflows. How to manage residual risk, hazards, and mitigations in one living model. How teams can stop duplicating effort and start collaborating across silos. This is essential viewing for: Risk Managers and Quality Engineers Systems Engineers and Product Developers Anyone preparing for FDA, ISO 14971, or EU MDR audits Teams looking to streamline their risk traceability and design documentation 🎯 It’s time to stop treating risk as a checkbox—and start treating it like the central nervous system of your design. 📩 Contact Larry: larry@foxsolution.net 📁 Design Control Webinar Registration Link: https://forms.monday.com/forms/115a8b...