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compliance with IEC 62304 (MDD62304)


Description
This course details how to comply with IEC 62304 for embedded software in medical device or standalone software.
The course will cover the requirements and how to apply them. Examples will be used for a better understanding.
short exercises will be done during the course to check the level of understanding and an assignments will be used for continuous evaluations evaluation.
Content
  • Introduction-classification
  • test_introduction
  • risk management
  • software risk management
  • risk management plan
  • FMEA
  • risk management report
  • Software requirements
  • software requirements specifications
  • specification requirements
  • architecture
  • architecture
  • architecture
  • SDS
  • SDS
  • study case 4
  • software detailed requirements
  • verification-testing
  • test_report
  • Test report
  • software maintenance
  • software maintenance example
  • software configuration management plan example 1
  • software configuration management plan example 2
  • software management procedure example
  • configuration maintenance
  • survey_1609495570
Completion rules
  • All units must be completed
  • Leads to a certificate with a duration: Forever
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