Risk management is understood as a continuous iterative process throughout the entire life cycle of a device, requiring regular systematic updating. Though Risk management has been a requirement in MDD also, EU MDR places greater emphasize on this area. EU MDR has provided detailed description on how manufacturers should establish, document, implement and maintain a system for risk management. Risk management system should be carefully aligned with and reflected in the clinical evaluation for the device, including the process of clinical risks that needs to be addressed as part of clinical investigations, clinical evaluation and post-market clinical follow up. Risk Management and clinical evaluation processes should be inter-dependent and should be frequently updated.
Considering the importance of risk management with EU MDR, this webinar is designed to focus on the following aspects of risk management in EU-MDR perspective.
- Risk management requirement under MDR
- Risk-Benefit analysis
- Clinical Investigations under MDR
- Expectations above and beyond MEDDEV 2.7.1, Rev 4
- Conformity Assessment Procedures