Freelancer profile translated to English.
Back to original languageAbout Laurane
As a writer specializing in the clinical evaluation of medical devices, I am qualified for writing and updating State of the Art (SOTA) and Clinical Evaluation Reports (CER). My work strictly complies with the requirements of the new European Medical Device Regulation (MDR 2017/745), as well as the rigorous expectations of notified bodies.
French
Native or bilingual
English
Fluent
Spanish
Conversational
Remote only
Primarily works remotely
Experience
- Bitmakers LabClinical Research EngineerMEDICALOctober 2018 - Today (7 years and 8 months)Île-de-France, FranceClinical Evaluation: Proven expertise in writing and updating CERs, ensuring that medical devices meet the performance and safety criteria required by the European regulation.Regulatory Compliance: Mastery of MDR 2017/745 requirements, ensuring that all clinical evaluations comply with current standards and the expectations of notified bodies.Collaboration with Notified Bodies: Experience working closely with notified bodies to facilitate the certification and approval process for medical devices.
- BitmakersClinical Affairs InternMEDICALApril 2018 - September 2018 (5 months)Île-de-France, FranceImplementation of ISO 13485 quality documentation related to clinical activities:- Clinical evaluation SOPs- Clinical investigation SOPs- Associated forms
- Aarhus UniversityBiomechanics InternJanuary 2018 - March 2018 (2 months)DenmarkModelization of the mechanic behaviour of the skin.State of the art of the knowledge about the skin:The skin is knows as a nonlinear anisotropic viscoelastic locally orthotropicmaterialState of the art of the current mathematical models used to modelize the skinbased on the finite element method:There are several models of the human skin (Mooney-Rivlin, Ogden, Fungetc.), more or less complex, which take account of more or less characteristicsof the real human skin: one or several layers, uniform material or fibre network.Comparison of several models with Comsol.
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Education
- Internal Audit AptitudeAptitude à l'audit interne
- Master 1 Public Health and Environment (SPE), Statistics and Clinical InvestigationsNancy School of Public Health2018Master 1 Santé Publique et Environnement (SPE), Statistiques et Investigations cliniques
Skill set (5)
Categories
- Other