Fleur Monnet
Qara R & d Specialist @Diabeloop
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WORK HISTORY
Qara R & d Specialist @Diabeloop
Grenoble, FR
Diabeloop is a company which develop an automated insulin delivery (AID) system for Type 1 Diabetes-I am currently in the quality team and I am in charge of- Maintain of R&D process - Creation of technical documentation for design validation (Clinical trial)- Usability - Product cybersecurity- Maintain of existing technical documentation- Preparation of MDR for product and QMS - Participation of MDR Audit - Work with different suppliers: Japan - South Corea - Follow up of accompanying documents (IFU, Training material, trouble shooting guide) Standard: ISO13485 ISO62304 ISO62366 ISO14155 ISO27005ISO82304
EDUCATION
Polytech Lyon
Master’s Degree, Biomedical/Medical Engineering
Université Paris-Saclay
Master 2 Innovation, marchés et science des données , Santé
ABOUT FLEUR MONNET
QARA R&D specialist chez Diabeloop
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