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Combined Class I SaMD/Physical Medical Device QMS
Indicative cost
£14,700.00
Development of a combined software as a medical device and physical medical device Quality Management System (QMS) sufficient for Class I/General IVD 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.
Combined Class I SaMD/Physical Medical Device QMS 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
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Class I Medical Device, General IVD or Class A IVD Self Certification CE Marking
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Class IIa/b/Non-General/Class B, Class C or Class D IVD Self Certification CE Marking