Medical Device Consultants
Our medical device consultants help manufacturers, sponsors and distributors in the Asia Pacific comply with requirements and standards, issued by organisations such as the US FDA CRF 820, and the ISO 13485:2016 Quality Management System for Medical Devices and ISO 14971 Risk management for medical devices.
Our ISO 13485 consultants are experienced at providing a wide range of services, from our architects designing a new facility, through to our QMS / ISO 13485 consultants writing a Quality Management System. We believe that our consultants will be faster as we have a huge library of past projects to draw upon.
Our services include: