Hello, I am Geneviève Laumen, a dedicated freelance medical writer with over three years of invaluable experience in the medical device sector.
After studying (neuro)biology, I decided to apply my scientific skills and knowledge to the medical device industry.
In my role as a Clinical Evaluations Manager, I specialized in preparing comprehensive clinical evaluation documents tailored to various regulatory frameworks, including MDR, AIMDD, MDD, CFDA, TGA, and FDA. In addition, I am adept at in conducting systematic literature searches to ensure the highest standard of quality.
My services
With 3.5 years of experience as a Clinical Evaluations Manager, I specialize in preparing various clinical evaluation documents tailored to meet the needs of medical device companies. My services include the preparation of:
- Clinical Evaluation Plans (CEP)
- Clinical Evaluation Reports (CER)
- Summary of Safety and Clinical Performance (SSCP)
- State-of-the-Art (SOTA) Analyses
- Systematic literature searches
My key skills are:
- Organized and structured way of working
- In-depth knowledge of relevant guidelines such as MDR, MDCGs, etc.
- Analytical thinking
- Professional and friendly communication
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