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.