Risk management
ISO 14971, as revised in 2019, with the ISO/TR 24971:2020 guidence on application is the most relevant risk management standard to be applied for medical devices. A risk-based approach is also required in process standards like ISO 13485:2016
We can help you with:
- In-house standards and regulations training
- Development of risk-based processes, procedures and templates
- Process implementation
- Risk management techniques
– Usability
– Cyber security
– Software risk management
– Process risk management - Integrating risk management with your quality system
- Integration of risk management to IEC 60601-1, 3rd Edition
- Risk management process audits
- Handling risk management activities
- Risk analysis methods
– Fault tree analysis
– Failure mode and effect analysis
– Hazard and operability analysis
Contact me for further information
Robert Ginsberg
Office +46 8 621 01 05 or send me an mail