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£11,025.00
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.
Digital system fees
Standards audits/certifications