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.
After studying (neuro)biology, I decided to apply my scientific skills and knowledge to the medical device industry. As a Clinical Evaluation Manager, I have prepared clinical evaluation documents for medical devices under MDR, AIMDD, MDD and for the NMPA, supported literature search projects for the TGA and FDA and conducted systematic literature searches.
My services
With 3.5 years of experience as a Clinical Evaluations Manager, I specialize in the preparation of 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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