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Expertise

With over 18 years of experience in the medical device industry, I support manufacturers and distributors of medical devices and in-vitro diagnostics in the strategic development, documentation, and ongoing compliance with requirements in the areas of quality management and regulatory affairs. Feel free to contact me for a tailored and pragmatic solution.

Qualifications

A Bachelor's degree from Wismar University of Applied Sciences (Faculty of Economics) and a Diploma in Translation from the Institute of Linguistics Educational Trust) form the foundation of my academic background. 

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In addition, I am a certified lead auditor per ISO 9001:2015 and ISO 13485:2016.

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To effectively address the diverse challenges in the medical device industry, continuous education on regulatory and normative developments is essential for me.

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Medical fields of application 
(selection)

  • Aesthetic dermatology

  • Surgical ophthalology

  • Otorhinolaryngology (ENT)

  • Stomatology/Orthodontics

  • Gynaecology

  • Nephrology

  • Orthopedic surgery

  • Oncology/Tumour subtyping

  • Diagnostic imaging

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