Conducted IEC62304 Software Validation and Created Software Development Technical File for IEC 60601-1 3rd Edition submission

Posted by on April 3, 2017 in Design Projects

Challenge

Customer needed IEC 62304 Software Validation and Software Development Technical File for new Medical Device IEC 60601-1 3rd Edition submission.

Actions

  • Wrote Software Development Plan.
  • Created Software Requirements Specification.
  • Oversaw creation of Software Design Specification.
  • Led software Risk Analysis and tracing.
  • Worked with Customer to perform software Unit, Integration and System Testing.
  • Created and wrote Software Problem Solving and Maintenance Processes.
  • Created and wrote Software Configuration Management Process.
  • Created overall Trace Matrix for software.
  • Assembled IEC 62304 compliant Software Development Technical File.

Result

Customer was able to get CE Mark for the new product.