Physical Medical Device (Class I/General IVD) QMS

Indicative cost

£10,290.00

Development of a physical medical device Quality Management System (QMS) sufficient for Class I/General IVD self-certification route.

The QMS can be delivered as a harmonised bolt-on to a SaMD QMS or delivered as a standalone QMS.

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.

It is also possible to deliver the QMS as a series of Word documents and templates to be stored in the Client’s Document Management System.

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Physical Medical Device (Class I/General IVD) QMS

Standards

  • Relevant Class I aspects of ISO 13485:2016 (Medical devices QMS)
  • Full compliance to ISO 14971:2019 (Medical devices — Application of risk management to medical devices)

Additional activities (Client responsibility)

Digital system fees

Standards audits/certifications


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