The Qmed Podcast

In this episode we're proud to welcome Dr. Bassil Akra. We are discussing the MDR - the new regulation and changes to come seen from the side of the Notified Body and touch on important topics such as Technical Documents, new reports such as SPUR and SSCP and use of clinical evidence from equivalent products for low risk class products.

In this episode we’re joined by Sandra Ferretti from the Obelis Group and Authorised Representative out of Brussels and we are discussing the EUDAMED database and the role of the Authorised Representative under the MDR.

In this episode we're guested by Semih Oktay, President and founder of CardioMed Device Consultants. We touch upon getting an overview of FDA structure and organisation and changes to come by June 2019, Risk classification, FDA approval processes and more.

In the first episode of The Qmed Podcast we’re joined by Hilde Viroux from HCL Technologies, to talk about MDR conversion strategy, including maximum use of ‘grace period’, product prioritization, product rationalization and more.