“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