The regulatory landscape is evolving: medical device regulators are expecting more mature risk management systems and processes. Further, recent standards revisions and emerging regulations - such as the European Medical Devices Regulation (MDR 2017/745) - show an increased emphasis on patient safety.
However, a mature risk management system does more than satisfy regulators and protect patients. It can boost products sales, increase customer loyalty, reduce the chance of product liability claims, and decrease your time to market. In this white paper, we discuss how the regulatory environment is changing and what you need to know to get the most out of your risk management system. You will learn:
- Key indicators of this regulatory shift
- The role of standards in reducing risk
- How to begin identifying key hazards and risks associated with your device
- How to identify appropriate risk controls
- and more.
Download our 9-page white paper to learn more about the future of risk management for medical device companies.