The role of Risk Management has come to the forefront of Medical Device management and operations. Changes brought about by ISO 13485, MDR, and MDSAP emphasize that consideration of risk must be present in every process. More than that, the thought processes behind risk-based decisions must be documented. The goal of this presentation is to provide an awareness of the role of Risk Management in the QMS.
The discussion will cover:
- Industry’s need for risk management
- The core idea behind risk management
- ISO 14971:2019 what is changing?
- Avoid auditing pitfalls