The authorization of medical devices is a demanding process. We support our customers from start to finish, from the initial support in the starting phase of a project up to the reliable authorization process at any given institution for almost all markets worldwide.
The first step is to classify the medical devices (risk classes I, IIa, IIb, III) as well as IVD-devices (risk classes A, B, C, D). Naturally, we research the applicable standards and particular norms and check the regulatory requirements.
