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Dr Alexander Theis
Key Competencies
Alexander Theis has a PhD in chemistry and 18 years' experience in the medical devices industry and the consulting sector.
Recent Focus
Since 2019, Alexander has played a significant role in establishing our internal Medical Devices Regulatory group as a Senior Managing Consultant, specialising in technical documentation and regulatory affairs. He has been advising clients in all aspects of international approvals, offering expert support in risk assessments, biological evaluations, clinical evaluations, and qualification and validation.
Special Competencies
- Medical Device Regulation MDR (EU) 2017/745
- Risk analysis (ISO 14971)
- Biological evaluations (ISO 10993)
- Clinical evaluations
- Qualification and validation
- International approval