Medical Device Engineering Lunch & Learn

Service Description

HeurNova offers an engaging, fast-paced Lunch & Learn session designed to introduce your team to the core principles of medical device engineering and the regulatory systems that govern them. In just 45–60 minutes, participants gain a clear understanding of how design controls, risk management, and validation work together under ISO 13485, ISO 14971, and FDA 21 CFR 820/QMSR. Using real-world examples from manufacturing and product development, the session helps engineers, quality professionals, and leadership teams understand how smart design and proactive compliance reduce risk, prevent findings, and accelerate product readiness. Topics include: Design controls and traceability Risk management (FMEA, hazard analysis, ISO 14971) Process validation fundamentals (IQ/OQ/PQ) How regulatory expectations drive good engineering practice Common audit pitfalls — and how to prevent them Perfect for engineering, QA/RA, and operations teams seeking an accessible introduction to device compliance and lifecycle management.