On December 1, 2019, the third edition of the Organization on International Standards (ISO) 14971 was released, bringing the medical device industry back to a single recognized version of risk management. While the overall processes remain unchanged, the scope of risk management has expanded to include data and security, as well as an increased focus on production and post-production activities.
Moving forward, manufacturers will be required to clearly define intended clinical benefits of medical device(s) and properly evaluate them for both individual and overall residual risks after completion of mitigation activities. Manufacturers must also ensure that documentation of the conclusions of risk management activities are recorded within the completed risk management reports.
Access NAMSA’s White Paper, “Risk Management Systems: Implications of ISO 14971, ISO/TR 24971 and EU MDR Updates,” as Rich Granquist (Sr. Quality System Consultant, NAMSA) leads a discussion on:
- Implementation Guidelines
- Major Updates
- Implications of the Updates
- Inclusion of Data and Security Systems
- Schematic Representation of Risks
- Individual Residual Risks and Overall Residual Risk
- Benefits Risk-Analyses
- Production and Post-Production Information
- Risk Management Review
- ISO/TR 24971:2020
- EN ISO 14971:2019 and the EU’s Regulation 2017/745 on Medical Devices (MDR)
Please fill out the form below to access this white paper.