MedTech Impuls digital
A Detailed Overview of Compliant Technical Documentation and Clinical Studies for EU MDR/IVDR

22. Februar 2023 von 15:30 bis 17:00 Uhr


In this talk, Requalite Experts will provide information on the best practices of preparing compliant documentation for medical device manufactrurers as per new EU regulations of IVDR and MDR. In particular, we will discuss on how to create your technical file, establishing the performance evaluation reports, conducting systematic literature search, planning post-market activities, integrating risk management, and quality management. In addition, we will provide an overview of clinical studies for your devices with a hands-on case study of a COVID device.


Dr. Hakan Inan (Managing Director), Anne Ziel (Clinical Expert), Dr Ayse Tekinay (Clinical Study Director), Dr Mustafa Koksal (Regulatory Affairs Director, MDR Expert).

About Requalite: Requalite is a Regulatory Affairs and Clinical Study Service Company located at Munich. We provide technical support to medical device manufacturers for their needs in compliant IVDR-MDR preparations by helping to create all required plans, files, documentations, and reports. Requalite also provides full CRO services to conduct clinical performance and investigation studies in EU.


Die Veranstaltung ist kostenlos.


Forum MedTech Pharma e.V. – Dr. Frank Miermeister (