ISO Services

“Safety and quality are non-negotiable in the medical devices industry” and we operate to ISO 13485 standards.

In addition, we have successfully helped other facilities to obtain their ISO 13485:2016 certification.

ISO 13485:2016 Medical Devices

  • We can support you in moving your ISO 13485:2012 to the ISO 13485:2016 Standard

  • We can also support you in setting up your own manufacturing facility and develop your quality system to the ISO 13485:2016 Standard

ISO 62304 Software Life Cycle

  • We can guide you in developing your software to the ISO 62304 Standard

  • We can also develop bespoke monitor software and apps to the ISO 62304 Standard

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