European Medical Device Regulation and Entry into EU Market

​Special-In person:

​EU has introduced a new Medical device(MDR) and in vitro diagnostic device regulation (IVDR) to obtain CE mark, which impacts more than 500,000 medical devices. The manufacturers who want to enter EU market now must comply with a complex and more stringent requirements not only to obtain the certification but also maintain it during the life time of their devices.

​Dr Hakan Inan, Managing director of Requalite from Munich-Germany, will talk about the Pathway to EU Market entry through new regulatory landscape and will provide insights and practical solutions for medical device manufacturers and startups for their Journey into one of the biggest medical device markets in the world.

​About Requalite

​Requalite is a medical device Regulatory Affairs and Clinical Study services company located at the heart of Europe, in Munich-Germany. Requalite provides full CRO services for Clinical Studies and technical support to manufacturers of medical devices in accordance with EU regulations of MDR and IVDR. Requalite consults manufacturers of in vitro diagnostic and medical devices on the planning, preparation, execution, and reporting of all required technical documentation for existing as well as novel devices to obtain CE-marking.

​About Hakan Inan, PhD

​Dr Hakan Inan is the Founder and Managing Director of Requalite. He is also contributing and guiding the technical projects. He obtained his PhD at Nanotechnology and has strong research experience in In Vitro Diagnostic device and assay development for Cancer applications. His scientific expertise is in the field of Hematology, Immunology, and Oncology. He accumulated years of scientific and research experience as a PhD student and Postdoc at Stanford (Cancer Early Detection Center) and at LMU-Munich.