IEC 62304 main processes

Rami.Azulay March 9th, 2011 Posted by Rami Azulay( ) IEC 62304

IEC 62304 addresses the following main processes:

  • Software development plan
  • Software development
  • Software requirements analysis
  • Software architectural design
  • Software detailed design
  • Software unit implementation and verification
  • Software integration and integration testing
  • Software system testing
  • Software release
  • Software maintenance
  • Software risk management (refers to ISO 14971)
  • Software configuration management
  • Software problem resolution


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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