Risk Management

The ISO 14971 is raising the expectation for Risk Management to a higher level

We can help you with:

  • Inhouse training in standards and regulations
  • Development of processes, procedures and templates
  • Implementation of the processes
  • Software risk management
  • Process risk management
  • Integrating Risk Management in your quality system
  • Integration of Risk Management to IEC 60601-1, 3rd Edition
  • Auditing of your Risk Management process
  • Leading Risk Management activities, Risk Manager role
  • 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 a mail