IEC 62304 for engineers

The IEC 62304 – Medical device software – Software life cycle processesis a standard which specifies life cycle requirements for the development of medical software and software within medical devices.

The awareness training is 8 hours and structured as follows:

  • 2 hour ‘audit’ practice
    • During this sessions, we practice what happens during an audit
  • 4 hour IEC 62304 theory
    • General requirements
    • Software development process
    • Software maintenance process
    • Software risk management process
    • Software configuration management process
    • Software problem resolution process
  • 2 hour open interaction & questions

Contact me for dates and pricing.

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