With our Regulatory Affairs team we can support to transfer your concepts and prototypes from TRL3-5 to TRL7-9. Activities here include, but are not limitd to full-fledged Risk Management and Usability Evaluation. All activities are strictly following our ISO 13485 certified Quality Management System which allows to integrate our activities directly into the Technical Documentation of the new device which supports fast track to certification.

This is a service of

  • Viktor Kaplan-Straße 2/1, 2700 Wiener Neustadt, Austria
  • Incorporated Entity