We are composing complete documentations for CE-marking of medical devices of any class: streamlined and user friendly Quality Management Manuals and compelling Technical Files and Design Dossiers for being comfortably evaluated by the Notified Body.

>> Brochure: STEDY© Software Application for the Configuration of Technical Files and Design Dossiers

We know the actual regulations, standards and interpretations and revise documentations to free those of deviations and to respect latest requirements.

Our service packages are efficiently releasing You and they are moving Your organization forward - preventing You from having to add human resources.

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