Michael Hottner

Contact Details

Silver Member
RegEx Pro


My main topics of interest are
- R&D Design Controls,
- MDR/European Product Registration,
- US 510(k)s,
- Sterile Barrier System Validation and
- Biocompatibility.

I am looking forward to great don't hesitate to contact me!
Best wishes,


University & TÜV Rheinland
Ulm, Germany
Diploma Supplement, 2012
International Medical Device Regulatory Affairs
2012 To 2012

Munich, Germany
Diploma / Master, 2006
Medical Engineering
2001 To 2006

Job History

Senior Consultant R&D Project Management & Regulatory Affairs / Managing Director
Cologne, Germany
September 2015 - present

Consultant R&D Project Management & Regulatory Affairs (Freelancer)
Munich, Germany
May 2010 - September 2015

Project Engineer R&D Orthopedics
Munich, Germany
April 2006 - December 2009

Product Interests

  • Medical Devices