This course provides a comprehensive overview of medical device risk management under the EU MDR, EN ISO 14971:2019/A11:2021, and the new ISO 10993-1:2025. Participants will learn how to establish, implement, maintain, and document an integrated risk management process throughout the entire medical device lifecycle, while ensuring consistency between general risk management and biological risk evaluation. The training focuses on the practical application of regulatory requirements, risk analysis methodologies, risk control strategies, and documentation expectations from Notified Bodies. Special attention will be given to the integration of ISO 14971 and ISO 10993-1:2025 requirements, enabling participants to develop a coherent and effective risk management framework that supports compliance, product safety, and successful certification activities.
Participants will be eligible to request a complimentary 30-minute consultation with our experts.
At the end of the course, participants will receive the course slides and a Certificate of Competence.
Module I: Medical Device Risk Management Fundamentals
Module II: Integrating ISO 14971 and ISO 10993-1:2025
This course is intended for medical device manufacturers, Quality Management System (QMS) professionals, Quality Assurance personnel, Regulatory Affairs specialists, Research & Development teams, consultants, and all professionals involved in planning, implementing, and maintaining medical device risk management activities throughout the product lifecycle.
A basic knowledge of ISO 10993-1:2025 and the EU MDR is recommended.
€750 + VAT
10% discount for registrations completed by 30 July 2026
5% discount for registrations completed by 30 August 2026
10% discount on the second registration from the same company