(14 Aug 2019) R clinic on New European Medical Device Regulation (MDR) – Changes from the old MDD & Implications for Indian manufacturers
Talk title
New European Medical Device Regulation (MDR) – Changes from the old MDD & Implications for Indian manufacturers

Date - 14th August 2019. Time - 2:00 pm -3:00 pm

About the Speaker: Atonu Dutta
Head - Medical Devices (West Zone) & Lead Auditor- Det Norske Verita AS

Mr. Dutta is a lead auditor with a European Notified Body for CE certification of medical devices for over a decade. Has been auditing medical device companies for compliance to ISO 13485 certification as well. He is well versed with the development and implementation of the European Medical Device Directive and its various changes over the years. He has been employed by his notified body to audit device companies in Europe and U.S as well other than India. He is considered a key resource by his Notified Body for implementation of the new Medical Device Regulations of the European Union. His core experience includes various regulatory aspects connected to medical devices including design, manufacturing, testing, validations, pre-clinical and clinical evaluations.

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