The regulatory environment around Medical Devices has been tightening over the last few years, and we have moved with those changes.
The definition of a Medical Device encompasses a vast range of products from first-aid bandages and walking frames to CT scanners and non-active implants. We recognise that the regulatory framework is, as far as possible, linked to the degree of risk inherent in the device. This has seen us involved with a wide range of products, ranging from implants which are later to be irradiated, through to novel wound management systems. A common feature of our involvement in this area has been the application of our wide range of equipment and “GMP” systems to support device manufacture and to understand products compliance with various regulations such as, ‘Proposition 65’.