Our specialists from PROSYSTEM support you with our long-standing and manifold experience in the field of in-vitro diagnostics. We accompany you all the way from the idea of a product, the challenges of international product registrations to the downstream processes of already marketed products.
The aim of PROSYSTEM is to provide an extensive support to fulfill the complex requirements towards laboratories, healthcare facilities and manufacturer of in-vitro diagnostics in order to identify preconditions of a product registration to ensure marketing authorizations for the desired markets in a timely manner.

PROSYSTEM assists you within our services in:

  • The classification of your medical device according to Annex II of the directive 98/79/EEC
  • The identification of applicable standards and needed technical documentation
  • Performance evaluation
  • Assessment of already created documentation
  • Accompaniment in market registration, market entry and post production phases.

Please contact us for further detailed information about “In-vitro diagnostics” or a non-binding offer.