The physicist of biomechanical engineering on drug delivery systems (DDS) Dr. Faraj Abdelnour works for AB Certification as "Directeur Marquage CE" since 2011. After four years in Research Development for pharmaceutical laboratories dealing with sterile endo-vascular devices, he was in charge of French homologation and vigilance for surgical devices and Drug Delivery System, and relations with test laboratories at the French Ministry of Health. Dr. Abdelnour participated actively in the transposition into French Law of the AIMD 90/385 and MDD 93/42 as well the French rules for matério-vigilance and the creation of the French Agency AFSSaPS. He provides assistance for managing compliance with assessment and certification procedures throughout Europe and the Middle-East, and helps clients direct their marketing efforts in the reimbursement environment in those markets, particularly in France and ME. His specialties are Medical Devices & In Vitro Diagnostic Devices, Vigilance and Post-market surveillance, Audits - Due Diligence, clinical study design, ISO – 13485, Quality Management, Quality Systems Development/Implementation, Regulatory Affairs, Regulatory Strategy Consulting, Regulatory requirements outside Western Europe, Strategic Reimbursement and Pricing, Health Technology Assessment and Submissions, Trouble shooting with authorities and Integrated development of cost-effective clinical studies.
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