Updates to ISO 14971: “Application of Risk Management to Medical Devices,” and its companion Technical Report ISO TR 24971: “Guidance on the Application of ISO 14971,” are soon to be released.
Within the ISO 14971 updates, eight major changes are being made to the standard to address risk management of medical devices from inception to post-production. These modifications will impact both the risk management of new product development, as well as the risk management of existing products files.
ISO TR 24971 has also undergone a major revision; as such, the Technical Report provides extensive information on how manufacturers are to implement the newest version of ISO 14971 and also presents examples of risk management tools for device Sponsors.
The information in the recent ISO updates also align well with the EU’s Medical Device Regulation (MDR) 2017/745, particularly in the area of Post-Market Surveillance.
This webinar will discuss the major changes and updates and provide information as to why they are being made. We will also highlight the potential impact on new and existing risk management files, and how the new standard aligns with MDR.
Attendees who attend this webinar can expect to:
- Identify the major changes with the new version of the ISO 14971 standards
- Learn why the changes are occurring
- Comprehend the potential impact to medical device manufacturers’ risk management systems
- Understand the harmonization of risk management between the EU and U.S. regulations