Medical Device Engineering Seminar

Service Description

HeurNova presents a comprehensive seminar exploring the core principles, regulatory expectations, and practical applications that shape medical device engineering today. Participants gain a structured overview of design controls, risk management, validation, and quality systems in alignment with ISO 13485, ISO 14971, and FDA 21 CFR 820/QMSR. Through real-world examples and interactive discussion, the seminar bridges engineering theory with compliance execution — preparing attendees to design, verify, and validate safe, effective, and audit-ready medical devices. Topics include: Design Controls and the Product Development Lifecycle Risk Management (ISO 14971 / FMEA Integration) Verification and Validation (IQ/OQ/PQ / Process Validation) Documentation Architecture and Traceability Human Factors and Usability Engineering Post-Market Surveillance and Continuous Improvement Target Audience: Engineering, Quality, Regulatory, and Manufacturing professionals or students seeking foundational and applied understanding of medical device development.