Regulatory Affairs, Clinical Studies

• All steps to gain the CE mark
• Development of certification strategy
• Strategic planning of QM systems
• Consultancy at development and implementation of QM systems
• Compilation of technical files
• Clinical evaluation and clinical investigation
• Risk assessment
• Classification
• Expert opinions for notified bodies

To be able to cope with the rising demand for regulatory consultancy, I merged my regulatory activities with YES - Medical Device Services GmbH. YES offers you a one stop shop for all regulatory problems.

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