MDR/IVDR

Here you can find the current revision of the MDR/IVDR.

  • In-vitro-Diagnostic Regulation (IVDR)
    Download
  • IVDR Gegenüberstellung dt/en
    Download
  • Medical Device Regulation (MDR)
    Download

Registered users have access to a formatted version of the MDR, including a table of contents. This version is both translated into German and English:
Download

 

Presentations and Flyers

Here you will find flyers and booklets about special events, a summary of the currently offered seminars and a presentation about PROSYSTEM.

Certificates

Our ISO 9001 and ISO 13485 certificates can be found here.

  • PROSYSTEM – Certificate – ISO 9001_2015 (EN)
    Download
  • PROSYSTEM – Certificate 13485 (EN)
    Download
  • PROSYSTEM – Zertifikat – ISO 9001_2015 (DE)
    Download
  • PROSYSTEM – Zertifikat– DIN 13485 (DE)
    Download