ISO/TS 24971:2020

Apply For Services

ISO/TS 24971:2020 is a technical specification that provides guidance on how to implement risk management processes specifically for medical devices and in-vitro diagnostic medical devices (IVDs). It serves as a complement to ISO 14971:2019, offering practical advice on how to apply the principles of risk management in the context of medical devices.

ISO/TS 24971:2020 is a technical specification designed to complement ISO 14971:2019 by providing additional guidance for applying risk management principles to medical devices and IVDs. It focuses on practical, real-world implementation and emphasizes post-market surveillance, risk communication, and the integration of risk management with broader quality management systems. By following this guidance, medical device manufacturers can improve product safety, ensure compliance with regulatory requirements, and enhance stakeholder confidence in the safety and effectiveness of their devices.