Kinesys Consulting has expertise in both the medical device and medicinal product regulations under one roof. We coordinate our internal resources to offer the best outcome in relation to DDC compliance. 

We can help you demonstrate that the general safety and performance requirements relevant to your DDC are met and support you in obtaining CE Marking, a Notified Body Opinion (NBOp) or a Marketing Authorisation. 

Kinesys staff have extensive experience in the preparation and approval of over 100 global Marketing Authorisations. Dossiers have been prepared and submitted globally to EMA, FDA, national European agencies and others such as Health Canada, and TGA.

Based on this wide knowledge we guide and assist you through the pre-application activities, the submission preparation, the review process and the related Agency interactions for your drug-device combination