Regulatory affairs in medical technology are often perceived as an aggravating factor in the development of medical devices. Development department and the Regulatory Affairs department are sometimes rather confrontational towards each other, resulting in unnecessary friction losses. Solnovis has many years of experience in development and manufacturing and can therefore, as an RA consultant, find intersections between the sometimes conflicting requirements in order to quickly come to an efficient approach.
A large number of steps are required for the approval and market launch of medical devices. Depending on the target market and the local regulatory and normative requirements, we support you in the approval process (CE, USA and international) as well as in external and internal audits.
Our solution-oriented strategies ensure a cost-effective, efficient and rapid market launch of your medical product.
Solnovis is certified in the following areas:
