Quality Management Consultant

for ISO 13485 and Medical Device Directive MDD 93/42/EWG

As a producing enterprise in the medical field we are self-evidently certified according ISO 13485 and we are experts in the design of such systems especially for different manufacturing methods and processes.We can consult you in the design of your QM-system. The expertise we offer is:


  • Design of your QM-system according ISO13485 (Quality Manual, procedural instruction, etc.)

  • Design and care on validated processes

  • Follow up care of your existing Qm-system

  • Adaption of your QM-system towards the European Medical Device Directive MDD93/42/EWG

  • Design and follow up care of your technical product file according the MDD 93/42/EWG for certification of your medical products (including: MPG, MPV, MPBetreibV, MPG-TSE-V, etc.).

Contact Us

Creamedix GmbH


Königsberger Strasse 2

76356 Weingarten - Germany

Tel:  +49 7244 608265

Fax: +49 7244 608266