Task: Review the IEC 62304 Mapping
This task presents the main entry points into the IEC 62304 content.
Main Description

The main goals for this task are:

  • Review the main workflows
  • Review the mapping from the IEC 62304 objectives to the process elements supporting them.

Navigate to the IEC62304 view by selecting the correspondent tab.

Use the following evaluation sequence:

  1. Start by reading the Welcome page.
  2. Get familiarized with the main IEC 62304 material
    • Expand the IEC 62304 Objectives folder
    • Expand the IEC 62304 SW Risk Management Process
    • For each objective:
      • Review the description
      • Review the mapping
      • Capture comments for feedback
  3. Review the workflows:
    • Expand the Delivery Process folder
    • Drill down into the Med Dev - SW - ISDP process 
    • Capture comments for feedback