Medical Audit & CAPA Template


Compliance support for ISO 13485:2016 and FDA Title 21 CFR Part 820

This Medical Audit & CAPA Template helps reduce the time and effort costs of tackling internal and external compliance audits in the development of medical technology. The template contains preconfigured artifacts, processes, and traceable links between work items to simplify audit preparation and execution, and to help manage Corrective and Preventive Actions.

This template was designed for developers of:

  • digital health software (embedded, standalone, or as part of a mobile application)
  • any type of healthcare technology with regulatory compliance requirements.

Combine with the Medical Software Engineering Template for 360° MedTech development and compliance support!

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