Combined Class I SaMD/Physical Medical Device QMS

Name: Combined Class I SaMD/Physical Medical Device QMS
Price: 14700.00 GBP
Availability: InStock

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.

Category: Quality Management System Development and Standards Compliance

Description

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)