sufficient for Class I/General IVD (software) self-certification route.

The QMS should be implemented into the Client’s system used for tracking of software development (e.g. Confluence/Jira).  Add on apps for digital signatures (eg. Comala), testing (eg. TestRail or Zephyr) and risk management (eg. Risk Manager) will be required.

Standards

• Relevant Class I aspects of:
  • ISO 13485:2016 (Medical devices QMS)
  • IEC 62304:2006 Amd 2015 (Medical device software — Software life cycle processes)
• Full compliance to:
  • ISO 14971:2019 (Medical devices — Application of risk management to medical devices)
  • DCB0129:2018 (clinical safety risk management)

Additional activities (Client responsibility)

Digital system fees

Standards audits/certifications