Authorization support and regulatory affairs

Worldwide authorization

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.

ISO13485, 21 CFR Part 820, IEC EN 62304, IEC EN 62366, DIN ISO14971, IEC 60601, EN 61010, EN 61326, IEC 62133, DIN EN ISO 14155

– whatever the norms or particular norms may be, we keep the product file and take care of the technical documentation required in the authorization process.

What this means: supporting reliable
authorization first-hand.