Risk management

ISO 14971 is a harmonized and expected risk management standard to be used 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