When developing medical technology, it is important to align the technical properties of a device with the expectations of the prospective users. For this reason, our consulting services include the evaluation of new procedures and products with respect to their compliance with medical standards, the conditions in which they can be applied and possible indications. Furthermore, usability has to be adequately considered.


The requirements that medical products are expected to fulfil and the standards they are expected to comply with are subject to constant change. This may be due to new legislation, the revision of guidelines such as the MEDDEV guidelines or changes in the procedures of notified bodies.

Already at an early stage, careful planning of the licensing procedures and the clinical evaluation may thus become essential. It is also often necessary to coordinate such planning with a notified body. We consult our clients with respect to their licensing plans and possible alternatives. We then develop an expert draft for the clinical evaluation and present it to the notified body.

This includes the modalities of clinical evaluation according to MEDDEV 2.7.1. with the possibility of literature evaluation or clinical testing as well as possible alternative procedures.


Our consulting services also include market observation as well as product vigilance, for which the legal requirements have become more rigorous in recent years.  

Efficient tools for Post-Marketing Clinical Follow-Up (PMCF) are of particular importance.