European CE Marking
Technical File & Design Dossier Preparation
We work with your technical team to ensure there are no gaps in the technical documentation of your product and that it meets all European regulations. We are able to author complete technical files and design dossiers to obtain European approval.
Based on the proposed intended use, we author clinical evaluation reports according to MEDDEV 2.7/1, including detailed literature reviews and reviews of post-market information on similar products. We also evaluate whether a pre- or post-market clinical study is necessary, or if clinical data from equivalent products can be leveraged to secure CE marking approval.
We can conduct your post-market surveillance as necessitated by MEDDEV 2.12-1, including post market literature reviews and reviews of national adverse events databases.