Product development and regulatory approval

Quality is paramount

Users of medical software applications expect perfection. Thus, quality and quality management are both a regulatory requirement and a significant product feature for MeVis.

Based on many years of experience in the certification of medical products in different economic areas, the processes and quality standards of MeVis meet highest international standards. MeVis is certified according to EN ISO 13485:2016 and is capable either to develop products which fulfill the requirements as per 93/42/EEC (Europe), FDA 510k (USA) and CMDCAS (Canada) regulations and to have these products properly certified and registered.

Alternatively, our customers can obtain the required documentation to allow them to pursue the appropriate registration or they receive a fully registered "turnkey" product which can be customized as desired (branding).

We also support our customers in case of registration procedures in other markets - and meet the most challenging demands.