We are pleased to announce the launch of our new CORE licence - a new subscription type designed specifically for compact regulatory teams who need access for two professionals. Over the past year, many readers told us that their regulatory teams were growing, often from one to two specialists, and that they needed a practical way to share full access without moving to a larger multi-user licence. We listened. The CORE Licence…
Now Available: 2026 Media Guide from Global Regulatory Press Download your copy of our 2026 Media Guide from our “Advertise” webpage. Why advertise with the JMDR? The JMDR reaches one of the most specialised professional audiences in the global medtech sector: regulatory and quality experts. Advertising with the JMDR gives you direct access to the decision-makers and specialists responsible for compliance, strategy, and product lifecycle management in medical device companies…
The UKCA marking continues to reshape market access in the UK. In this free-to-watch webinar, Teresa Perry of Peritus Regulatory Consulting Ltd 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. Tune in to our FREE podcasts!
Now Available: JMDR 2026 Editorial Calendar We are pleased to announce the release of the Journal of Medical Device Regulation (JMDR) Editorial Calendar for 2026. Download your copy from our “Write for Us” webpage, which also provides key information for prospective authors on: Our readership Submission and publication dates Content, type and length of articles Submission and review process We look forward to your contributions as we continue to advance…
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. Tune in to our FREE podcasts!
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. Tune in to our FREE podcasts!
Global Regulatory Press offers several forms of advertising media: Journal: the reference source for medical device and IVD regulatory professionals around the world Online: on our website GlobalRegulatoryPress.com Email: with highly targeted recipients in the medical device and IVD industries who have actively signed up and are therefore genuinely interested in the content Find out more about the advertising options available to you by downloading a copy of our 2025…
Do you want to publish an article in the Journal of Medical Device Regulation? We are always happy to consider any articles we receive. Our Editorial Calendar for 2025 is out now. To find out more about getting an article published in the Journal, please visit the Write for Us page on our website and download a copy of our 2025 Editorial Calendar.
The November 2024 issue of the Journal of Medical Device Regulation will soon be available for subscribers. This latest issue of the JMDR will look at the following topics: Interview: Katherine Wang talks to the JMDR about China’s draft ‘Medical Device Administrative Law’ An analysis of the EU MDCG recommendations concerning the content of a Clinical Investigation Plan and an Investigator’s Brochure Canadian regulatory framework for software-based medical devices and…
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…
The June / July 2024 Regulatory Bulletin for subscribers to the Journal of Medical Device Regulation is now available for downloading from our website. Our Regulatory Bulletins contain news snippets on select regulatory topics: the full, detailed news coverage will appear in the Journal as normal. The Bulletins are released between issues of the Journal to keep subscribers up-to-date on some of the most important regulatory changes as they happen.…
The February 2024 issue of the Journal of Medical Device Regulation will soon be available for subscribers. This latest issue of the JMDR will look at the following topics: EUDAMED: Important considerations for ensuring preparedness and compliance An overview of the medical device regulations in the Islamic Republic of Iran IVDR implementation – important lessons to learn and apply Monitoring of IVD clinical performance studies – the role of GCP…
Global Regulatory Press offers several forms of advertising media: Journal: the reference source for medical device and IVD regulatory professionals around the world Online: on our website GlobalRegulatoryPress.com Email: with highly targeted recipients in the medical device and IVD industries who have actively signed up and are therefore genuinely interested in the content Find out more about the advertising options available to you by downloading a copy of our 2024…
Are you interested in writing an article for publication in the Journal of Medical Device Regulation? If so, please visit our Write for Us page on our website and download a copy of our 2024 Editorial Calendar.
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. Tune in to our FREE podcasts!
The June / July 2023 Regulatory Bulletin for subscribers to the Journal of Medical Device Regulation is now available for downloading from our website. Our Regulatory Bulletins contain news snippets on select regulatory topics: the full, detailed news coverage will appear in the Journal as normal. The Bulletins are released between issues of the Journal to keep subscribers up-to-date on some of the most important regulatory changes as they happen.…
The March / April 2023 Regulatory Bulletin for subscribers to the Journal of Medical Device Regulation is now available for downloading from our website. Our Regulatory Bulletins contain news snippets on select regulatory topics: the full, detailed news coverage will appear in the Journal as normal. The Bulletins are released between issues of the Journal to keep subscribers up-to-date on some of the most important regulatory changes as they happen.…
University courses specialising in medical device regulatory affairs are becoming increasingly common. In our first podcast, 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. Secondly, Orin Chisholm discusses how the Association of Graduate Regulatory Educators (AGRE) – an international association for regulatory education professionals and students – can help improve…
The December 2022/January 2023 Regulatory Bulletin for subscribers to the Journal of Medical Device Regulation is now available for downloading from our website. Our Regulatory Bulletins contain news snippets on select regulatory topics: the full, detailed news coverage will appear in the Journal as normal. The Bulletins are released between issues of the Journal to keep subscribers up-to-date on some of the most important regulatory changes as they happen. This…
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. Tune in to our FREE podcast! In this interview, find out answers to the following questions: What are the key changes in relation to running clinical trials for medical devices since the adoption of the EU MDR? Is the MDR already having a noticeable…
The September/October 2022 Regulatory Bulletin for subscribers to the Journal of Medical Device Regulation is now available for downloading from our website. Our Regulatory Bulletins contain news snippets on select regulatory topics: the full, detailed news coverage will appear in the Journal as normal. The Bulletins are released between issues of the Journal to keep subscribers up-to-date on some of the most important regulatory changes as they happen. This latest…
The June/July 2022 Regulatory Bulletin for subscribers to the Journal of Medical Device Regulation is now available for downloading from our website. Our Regulatory Bulletins contain news snippets on select regulatory topics: the full, detailed news coverage will appear in the Journal as normal. The Bulletins are released between issues of the Journal to keep subscribers up-to-date on some of the most important regulatory changes as they happen. This latest…
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. Tune in to our FREE podcast! In this interview, hear Val answer the following questions: Are there particular challenges faced by industry by having potentially different regulatory requirements applied by various regulatory authorities around the…
The March/April 2022 Regulatory Bulletin for subscribers to the Journal of Medical Device Regulation is now available for downloading from our website. Our Regulatory Bulletins contain news snippets on select regulatory topics: the full, detailed news coverage will appear in the Journal as normal. The Bulletins are released between issues of the Journal to keep subscribers up-to-date on some of the most important regulatory changes as they happen. This latest…
Dr Kevin Fu, Acting Director of Medical Device Cybersecurity at the US Food and Drug Administration, talks exclusively to the JMDR in our latest expert podcast session conducted by Christopher Fulmer. Tune in to our FREE podcast! In this interview, hear Dr Fu answer the following questions: What agencies in the USA does the FDA interact with to help ensure cybersecurity issues and threats are addressed? What role do each…
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 Tune in to our FREE podcast! Listen to Christina discuss the following: BVMed has recently established an Environment and Sustainability Department to place a stronger focus on climate protection and sustainability goals in the association’s work. What general topics will this Department be addressing…
The December 2021 Regulatory Bulletin for subscribers to the Journal of Medical Device Regulation is now available for downloading from our website. Our Regulatory Bulletins contain news snippets on select regulatory topics: the full, detailed news coverage will appear in the Journal as normal. The Bulletins are released between issues of the Journal to keep subscribers up-to-date on some of the most important regulatory changes as they happen. This month's…
Haroon Atchia and Anna Novakovich of Quality First International talk to the JMDR about the importance and understanding of medical device sustainability Tune in to our FREE podcast! Listen to Haroon and Anna answer questions on the following topics: In your opinion, are medical device companies aware of the full environmental impact of their devices? Does this awareness vary through the different lifecycle stages of the device? Most device companies…
The September/October Regulatory Bulletin for subscribers to the Journal of Medical Device Regulation is now available for downloading from our website. Our Regulatory Bulletins contain news snippets on select regulatory topics: the full, detailed news coverage will appear in the Journal as normal. The Bulletins are released between issues of the Journal to keep subscribers up-to-date on some of the most important regulatory changes as they happen. Regulatory Bulletins are…
July's Regulatory Bulletin for subscribers to the Journal of Medical Device Regulation is now available for downloading from our website. Our Regulatory Bulletins contain news snippets on select regulatory topics: the full, detailed news coverage will appear in the Journal as normal. The Bulletins are released between issues of the Journal to keep subscribers up-to-date on some of the most important regulatory changes as they happen. Regulatory Bulletins are only…
Dr Christina Ziegenberg, Deputy Director General of the German industry association, BVMed, and JMDR Editorial Advisory Board member talks exclusively to Marija Capek Tune in to our FREE podcast! Listen to Christina answer questions on the following topics: Like many other countries, Germany’s medtech industry has been hit hard financially by the coronavirus pandemic, for example because of postponed operations. What is being done to support the industry in this…
June's Regulatory Bulletin for subscribers to the Journal of Medical Device Regulation covers regulatory changes in: Australia Brazil China El Salvador the EU Indonesia Japan Korea (Republic of) Pakistan Switzerland USA What are Regulatory Bulletins? Regulatory Bulletins contain news snippets on select regulatory topics: the full, detailed news coverage will appear in the Journal as normal. The Bulletins will be released between issues of the Journal to keep subscribers up-to-date…
Cristina Murgueitio, Executive Director of ASEDIM – Ecuador’s medical device association – answers the following questions posed by JMDR subscribers in our new FREE podcast: Is Ecuador’s medical device legislation in accordance with the laws of, for example, the USA or European Union? In particular, does Ecuador use the same definition of a medical device and accessory as any of the major markets? What are the classification rules? Do all…
Tracey Duffy & Prof. John Skerritt of the Australian Therapeutic Goods Administration (TGA) talk exclusively to Marija Capek of the JMDR. Tune in to the FREE podcast. Tracey Duffy leads the team specialising in medical device assessments and pre- and post-market surveillance of medical devices. She also leads the groups in charge of medical device and medicine testing. She is also the Management Committee member for Australia of the International…
Stephanie Goebel & Ortzi Olasolo from Beyond Conception talk to the JMDR about how to make a Quality Management System ready for the EU MDR. Watch/listen to our FREE PODCAST. Stephanie Goebel is Senior Consultant at Beyond Conception GmbH. She is a medical engineer with 15 years of experience in medical devices and combination products and is an expert in drug/device combinations. She also worked as an auditor, technical documentation…
