Risk Management

The Medical Device Regulation (EU 2017/745),in Europe has a strong emphasis on Risk Management. Herein, manufacturers of medical devices must identify foreseeable riks and implement risk mitigation measures throughout the design and production process. However, it is important to note that assessing the risks does not end here, as ISO 14971:2019, titled “Medical devices – Application of risk management to medical devices” requires companies manage risks as an ongoing internal process that lasts throughout a medical device’s product life cycle.