Kinesys Consulting works with you to navigate the complexities of medical device regulations, from classification queries to full regulatory submissions. We have the ability and expertise to develop the necessary technical documentation to demonstrate the conformity of your device to regulatory authorities, auditing organisations and Notified Bodies. 

Kinesys’ experience and expertise in this area is essentially based on high quality people, sound strategy and informed guidance. Kinesys in combining this experience and expertise can help you ensure a successful outcome.

We are strongly positioned to provide guidance and support in relation to drug device combinations, leveraging experience of our staff in both these areas.