Capabilities:

  • 30 years’ experience in medical device product development and regulatory processes
  • Working as consultant for startups, small and medium size companies with preparation of product documentation package in compliance with EU Medical Device Directive and FDA Design Control Requirements.
  • For larger Medical Device and Pharma companies typical with special tasks in the field of MDD and FDA Design Control requirements and Quality Management Systems
  • Strong R&D and Regulatory profile within product development of medical devices

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