Development + Certification

Support for the certification of medical products

  • CE-Marking of your medical products in Europe (93/42/EEC)
  • 510k of your medical product for FDA / USA
  • Implementation of a quality management system in your company (ISO 13485)
  • Providing the quality management representative for small companies

Development of medical devices

  • Development process (ISO 13485)
  • Technical expertise on medical lasers, fibre optics and clinical application
  • Project management
  • Implementation of a risk management process (ISO 14971)
  • Moderation and Conduction of a risk analysis
  • Clinical evaluation (acc. to MedDev 2.7.1)