Team

Sven Schaumann

Consultant

​Udo Warschewske

Senior Consultant

Abdallah Mohammedani

Junior Consultant

Michael Hottner

Consultant FDA

+49 (0) 151 27 56 99 70

Sven Schaumann

​Role:

​Senior consultant ​medical devices

​Academic degree:

Dipl.-Ing.

​Subject area:

​Electrical engineering and information technology

  • ​​Consultant for manufacturers of medical devices for more than 6 years
  • ​​> 10 years experience as developer (SW/HW), project manager, quality and regulatory affairs manager and strategy consultant for small and medium-sized companies
  • ​Participant in various standardization working groups
  • ​Member of the Regulatory Affairs Professionals Society (RAPS)

​+49 (0) ​331 27 97 89 89​

​

​Udo Warschewske

​Role:

Senior consultant ​medical devices & ​strategy

​​Academic degree:

​MBA

​​Subject area:

​​Biotechnology and medical technology

  • ​More than 20 years experience in the medical device industry
  • ​Management of medical devices as CEO, Quality Manager, Regulatory Affairs Manager, etc.
  • ​Many years of experience in the fields of image-guided surgery, mechatronic assistance systems, neuromodulation and vital data monitoring (hardware/software)
  • ​Quality management systems EN ISO 9001, EN ISO 13485, product registration and approval according to CE and FDA

​+49 (0) 331 27 97 89 89​

​

​​Abdallah Mohammedani

​Role:

Junior consultant

​​​Academic degree:

​Master of Science

​​​Subject area:

​​MSc Biomedical Engineering

  • ​Junior consultant with ​over 2 years experience in the medical device industry
  • ​Programming knowledge, technical background
  • ​Programming and validation of a complete ALM solutions (Polarion)
  • ​Extensive experience with MDR GAP analysis and MDR requirements

​+49 (0) ​331 27 97 89 89​

​​

​​​Michael Hottner

​Role:

​Consultant ​​FDA, ​risk management, biocomopatibility

​​​​Academic degree:

​Dipl.-Ing. 

​​​​Subject area:

​Micro and precision engineering, medical technology

  • ​Diploma supplement as Regulatory Affairs Manager International
  • ​Many years of experience with sterile products and infusion systems
  • ​Member of the Regulatory Affairs Professionals Society (RAPS)
  • ​Quality management systems EN ISO 9001, EN ISO 13485, product registration and approval according to CE and FDA
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