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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