Combined Class I SaMD/Physical Medical Device QMS Standards
- Relevant Class I aspects of:
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ISO 13485:2016 (Medical devices QMS)
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IEC 62304:2006 Amd 2015 (Medical device software — Software life cycle processes)
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- Full compliance to:
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ISO 14971:2019 (Medical devices — Application of risk management to medical devices)
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DCB0129:2018 (clinical safety risk management)
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Additional activities (Client responsibility)
Digital system fees
Standards audits/certifications