risk management procedure

Rami.Azulay July 30th, 2012 Posted by Rami Azulay( ) IEC 62304, IEC60601, ISO 14971, Risk Management, Software Lifecycle Management

Please review posts Risk management terminology, risk management file before reading this post

Risk management is supported by the following activities:

Risk management

  • Risk Assessment
    • Risk analysis (part of risk assessment)
      • Hazard/hazardous situations identification
    • Risk evaluation (part of risk assessment)
      • risk estimation
      • including acceptability evaluation
  • Risk control
    • Define effective control of the risk
    • Control implementation
  • Post production
    • Monitor risk control effectiveness

A device may contain some risks eventually, but it must be free from UNACCEPTABLE risks

IEC 60601-1 Third Ed clause 4.2 requires RM process (RMF)

Potential risk forms in QPack (partial fields) – click to enlarge:


About the author, Rami Azulay

Rami has over 24 years of experience in various software development and QA roles. Using his extensive knowledge of operations and quality, Rami was a main architect of the Orcanos software back in 2005 and later became Orcanos VP sales & marketing. Rami holds an MSC degree in Computer Sciences.

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