Risk Management ISO 14971

Risk management with medical devices

Risk management is the core element of medical device regulations. You must have heard about the "risk-based approach" when discussing medical devices or their quality management systems. Medical device risk management is most conveniently performed following ISO 14971, which is harmonized with Regulations 2017/745 (MDR) and 2017/746 (IVDR) and is US FDA recognised consensus standard.

Performing risk analysis is a process which produces a risk management file for each medical device. It consists of a risk management plan, risk analyses and risk management report. It should cover a wide array of different risk categories such as cybersecurity risks and usability risks. 

Our experts at Labquality have long-term experience in risk management and its different flavours and can support you in creating efficient and compliant risk management operations in your company.