Quality Management

C-Path Software Engineering can help your company plan, implement and maintain a quality management system designed for the manufacture of medical device products ensuring your quality processes and procedures are compliant with recognized industry standards.

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We offer assistance and support with the implementation and continuous improvement of quality management systems appropriate for medical device development. Our qualified ISO 13485/9001 Lead Auditor consultants can provide independent internal audit services; highlighting any of your processes that might require attention and confirming the readiness of your software for notified body audits and regulatory pre-market approval.

We have hands-on experience of implementing ISO 13485 and MDSAP quality management systems from concept to QMS certification and subsequent surveillance audits and offer services including writing, implementing and training on quality processes and procedures for a total product life cycle approach that include:

  • risk management processes;
  • design and development processes;
  • production/manufacturing processes;
  • feedback processes, CAPA and vigilance processes;
  • post-market surveillance processes.
  • We specialize in medical device software development processes including the quality management framework required for this to be effective.