2-Day Training Course in Risk Management for Medical Devices
Join us for this training course, where you’ll gain hands-on knowledge about key risk management concepts and the process steps according to ISO 14971:2019. We’ll also highlight specific regulatory requirements that apply to risk management and give you insight into the increased regulatory focus on risk management in the MDR and IVDR.
What you’ll learn:
- Regulatory requirements according to ISO 14971:2019 and MDR/IVDR
- Key concepts and definitions in risk management
- Step-by-step walkthrough of the process steps
- Methods and tools for risk analysis
- Elements of the risk management plan, report, file and traceability
- Integration of risk management into a product’s life cycle and QMS
Course material will be in English, verbal presentation and discussions varies between Swedish and English.
Who should attend?
Medical device professionals involved in risk management activities, who need to learn the basics, or anyone needing a refresher.