The UKCA – Now, Next, Navigating Ahead
The UKCA marking continues to reshape market access in the UK. In this webinar, Teresa Perry explains where the UKCA framework stands today and what changes are on the horizon, as well as offering practical guidance for navigating what’s coming next.
Posted: October 2025
The many ambiguities of the European Union’s Artificial Intelligence Act
A recording of our LinkedIn Live event with industry expert Cécile van der Heijden, where she answers questions on the particularities and real-world challenges of the European Union’s Artificial Intelligence Act and its impact on medical devices.
What’s allowed – and what’s not – when marketing medical devices online?
A recording of our LinkedIn Live event with industry expert Madhavi Bellamkonda, where she shares her expert tips on navigating social media and direct-to-consumer advertising for medical devices, with a particular focus on the USA. The session dives into the latest regulations, best practices, and real-world challenges, and answers questions from attendees.
FEMTECH: Innovationen und Herausforderungen in der Regulierung
In dieser Folge unseres Podcasts sprechen wir mit Natalie Gladkov, Leiterin Digital Health beim BVMed, über die spannende und hochaktuelle Welt der Femtech – ein wachsender Markt, der das Potenzial hat, die Gesundheitsversorgung weltweit nachhaltig zu verändern. Gemeinsam beleuchten wir die einzigartigen Herausforderungen, denen sich Unternehmen in diesem innovativen Bereich stellen müssen und sprechen über regulatorische Hürden und mögliche Lösungsansätze. Erfahren Sie mehr darüber, wie die Digitalisierung und neue Technologien die Frauengesundheit revolutionieren und welche regulatorischen Aspekte dabei zu beachten sind.
US FDA Pre-Submission Best Practices for Early-Stage Startups and Small Businesses
In this beginners’ podcast, Kristen and Mridul Mittal explain what FDA pre-submissions are and what purpose they serve, as well as how they work and how long they take. They discuss the FDA guidance designed to help applicants understand the pre-submission process, and provide practical advice for applicants wanting to use the pre-submission process to ensure everything runs smoothly and effectively.
Posted: September 2023
Conversations about Regulatory Education initiatives
University courses specialising in medical device regulatory affairs are becoming increasingly common. Jack Wong and Raymond Tong talk about the creation of the Regulatory Affairs Education Alliance (RAEA) and how it plans to help improve education standards in regulatory affairs.
Orin Chisholm discusses how the Association of Graduate Regulatory Educators (AGRE) – an international association for regulatory education professionals and students – can help improve the regulatory education of medical device professionals.
Clinical and regulatory challenges for manufacturers under the EU MDR
Mikaela Dimitriu & Marius Woitok provide in-depth answers to questions posed by JMDR subscribers on the clinical and regulatory challenges for manufacturers under the EU MDR.
A session on requirements for SaMD and AI/ML in medical devices
Val Theisz answers questions posed by JMDR subscribers on the regulatory requirements for SaMD and AI/ML in medical devices. The slides she uses are also available for free download alongside the audio and video files.
Cybersecurity challenges and opportunities for medical device companies in 2022
Dr Kevin Fu, Acting Director of Medical Device Cybersecurity at the US FDA, talks exclusively to the JMDR in our latest expert podcast session conducted by Christopher Fulmer
The views expressed in this podcast by the interviewer, Christopher Fulmer, are his own personal views and do not represent those of his employer.
Supporting the medtech industry to achieve its climate protection and sustainability goals
Dr Christina Ziegenberg, Deputy Director General of the German industry association (BVMed) explains what changes are happening in Europe and their effects on the medtech industry
The importance of medical device sustainability
Haroon Atchia and Anna Novakovich of Quality First International talk to the JMDR about the importance and understanding of medical device sustainability
Current challenges facing the medical device industry in Germany
Dr Christina Ziegenberg, Deputy Director General of the German industry association, BVMed, and JMDR Editorial Advisory Board member talks exclusively to Marija Capek
A session on regulatory requirements for medical devices and IVDs in Ecuador
Cristina Murgueitio, Executive Director of ASEDIM – Ecuador’s medical device association – answers questions posed by JMDR subscribers
The impact of COVID-19, as well as current and future challenges, for the Australian TGA
Tracey Duffy & Prof. John Skerritt of the Australian Therapeutic Goods Administration (TGA) discuss topical issues with Marija Capek of the JMDR
How should manufacturers update their QMS to meet the requirements of the European MDR?
Stephanie Goebel & Ortzi Olasolo from Beyond Conception talk to the JMDR about how to make a Quality Management System ready for the EU MDR
EUDAMED: What do companies need to know about actor registration and the management of legacy medical devices?
Richard Houlihan of Eudamed.eu in Brussels, Belgium and Sofia, Bulgaria discusses the latest EUDAMED developments with the JMDR
Medical device usability according to the MDR/IVDR; expectations of Notified Bodies and recommendations for manufacturers
Ferdinando Capece Minutolo of Confindustria Dispositivi Medici, Rome, Italy talks to the JMDR
A Notified Body’s perspective on the clinical evaluation requirements under Regulation (EU) 2017/745 on medical devices
Richard Holborow, Global Head of Clinical Compliance at BSI, UK chats to the JMDR
Developing cleaning instructions for reusable dental rotary cutting devices in the context of a risk analysis in the USA
Kristy Azzolin of the American Dental Association Science & Research Institute, LLC talks to Mario Nacinovich of the JMDR Editorial Advisory Board
