ISO Services

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

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

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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