Created Technical File for CE Mark submission

Posted by on April 5, 2017 in Regulatory & Standards Compliance Projects

Challenge

Customer needed updated IEC 60601-1 3rd Edition Medical Device CE Mark.

Actions

  • Led Risk Analysis and tracing.
  • Wrote Essential Requirements document.
  • Developed IEC 62366 compliant Usability Engineering file.
  • 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.
  • Assembled IEC 62304 compliant Software Development Technical File.
  • Created overall Risk Analysis, Requirements and Verification Trace Matrix.
  • Updated ISO 14971 compliant Risk Management file.

Result

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