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Sylvain Podesta
Complex Medical Device Department Manager @GMED
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WORK HISTORY
Complex Medical Device Department Manager @GMED
Ville de Paris, FR
Team Leader of auditors and technical file assessors Regarding 2017/745 regulation, ISO 13485 Standard and MSAP program in the fields of : wound care, Contraception, filler, skincare for specific medical device such as Device with drugs, MDOA, Aesthetics products, Decision maker for IVDR 2017/746 regulation, ISO 13485, MDSAP program Lead auditor for IVD products in different domains : Virology, Immune hematology, coagulation, blood typing. Multiple MDR et IVDR codes covered.
EDUCATION
Université Paris-Est Créteil (UPEC)
Maitrise science et technique
Excelia
Master's degree
SKILLS
ABOUT SYLVAIN PODESTA
Chef de Projet Certification pour l\'Organisme Notifié Français - Prise en charge, suivi et gestion d\'un portefeuille clients (Fabricants et sous-traitants de Dispositifs Médicaux de Diagnostic In Vitro)- Responsable d\'Audit et Auditeur dans le cadre des certifications volontaires (ISO 9001, ISO 13485), réglementaires (Directive 98/79/CEE) et Internationales (Canada, Taiwan) des Systèmes de Management de la Qualité de fabricant de Dispositifs Médicaux de Diagnostic In Vitro- Evaluateur dans le cadre d\'Examen CE de Type et Examen CE de la Conception de Dispositifs médicaux In Vitro liste A et B (Evaluation de dossiers techniques : Dossiers de Marquage CE).
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