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