qcompetence GmbH

525 West Monroe Street
Suite 23620
Chicago, Il, 60661
Toll Free: 1-866-735-3740

qcompetence - the partner for medical product manufacturers

We are a provider of consulting services concerning the registration of medical products (regulatory affairs), quality management and process management.

Our services:
Registration of medical products:
  • Strategic consulting and project management concerning product registration
  • Communication with local authorities
  • Researching relevant requirements and regulatorry consulting during product development
  • CE mark: Selection of conformity assessment procedures Creation of technical documentation in accordance with the EC directive for medical devices (93/42/EWG), taking into account risk analysis, ergonomics and clinical assessment
  • Creation of a 510(k) dossier for product approval in the USA Quality and risk management