Archives: Episode

• Why does an Importer/Distributor need to appoint a Notified Body?

  Recently MDCG issued the guidance on Article 16 of the EU MDR & IVDR. This provided some surprises. So now in certain circumstances, some importers or distributors will need a […]

• How to collect Clinical Data within the 21st Century [Jon Bergsteinsson]

  Clinical Data is key for the Medical Device Regulation MDR 2017/745. Today on this Podcast Episode, I have invited Jon Bergsteinsson from Smart Trial. And we will discuss Digital tools […]

• How to manage the IVDR transition period? [IVDR 2017/745]

  We are at 9 months of the EU IVDR 2017/746 date of application. So let’s t talk of the Transition period for such products. We have done that also for […]

• Is it a good idea to sue my Notified Body? [Erik Vollebregt]

  First of all, I am not encouraging anyone to sue anyone. This is only educative content to know what is possible and what is the best strategy to do it. […]

• Medical Device News – September 2021 Latest Updates

  This month we will cover a lot of specific rules that are applied in some countries: USA UK France Finland Switzerland And then we’ll look at Events planned, Notified Bodies, […]

• How to Certify a Software as Medical Device? (Dr. Abtin Rad – TÜV SÜD)

  Software as a Medical Device is really a difficult topic. First, because it is quite new in the EU Regulation, and second because we cannot make a generality and should […]

• Better to be a Consultant or a Full-time employee? [Lifescience industry]

  Let’s describe to you the life of a Healthcare industry consultant with Smahan Toughrai. Within this episode, we will ask the question like: Why would we choose a consultant job? […]

• What can we learn from the first MDR audits? [Martin Witte -TÜV SÜD]

  After few months of MDR, I proposed TÜV SÜD share with us the most common mistakes they find during their audits. And Martin Witte accepted to summarize some of them. […]

• Medical Device News – August 2021 Regulatory Update [MDR & IVDR]

  On the agenda for this month Episode we will talk about the latest news and here are few topics that I will present to you: Team-NB Position Paper Harmonized Standards […]

• How to implement Vigilance Reporting for MDR and IVDR?

  Within this Masterclass, I will explain to you how to implement a vigilance reporting system with all the links for all the documents we talk about. Vigilance reporting is a […]