In this final episode of our first season, Helene looks back at great interviews we've had and share some of her favourite conversations and takeaways. This is a great episode for those who are new to the podcast, but also for our avid listeners to make sure they haven't miss the important points from our talented guests. Have a great summer - See you in the fall!
The Qmed Podcast #9 with Heidi M. Mehrzad
Human factors and usability are terms often used interchangeably. Yes, it can be a tricky topic, and one that can create some confusion. Therefore, I've invited Heidi Mehrzad from HFUX Research to guide us on the difficult topic. Hope you will enjoy listening in and tap in on Heidi’s vast amount of experience.
In this episode of The Qmed Podcast we'll be joined by Richard Houlihan, to talk about "The EUDAMED database and the basic fundament behind". Being part of the European Commission MDR Eudamed technical management position Richard can provide a unique prospective on Eudamed’s inner workings and design bring a better understanding of the Eudamed technical challenges facing companies.
In this episode we are joined by Charlotte Piester from Sinua Partners and discuss how to use clinical and regulatory requirements as commercial competitive advantages within the MedTech industry, completely aligned with the changes to the MDR and the need for companies to carefully consider their claims, market access and which data to collect when – creating The Evidence Gap Plan.
In this episode of The Qmed Podcast we're joined by Ernesto Nogueira, to talk about key steps for SMEs to know about, regarding commercialisation when starting up the development of their innovative new medical device.
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, to talk about MDR conversion strategy, including maximum use of ‘grace period’, product prioritization, product rationalization and more.