Bringing clarity to medical device regulatory professionals all over the world
- The many ambiguities of the European Union’s Artificial Intelligence Act 9th May 2025 - Navigate the regulatory complexities of AI-powered medical devices with insights on the EU Artificial Intelligence Act: understand its horizontal scope and the implications for high-risk systems Read More
- Global news updates – May 2025 9th May 2025 - Get the latest international regulatory news from the JMDR May 2025 issue - concise, expert-curated updates to keep you ahead in the medical device industry Read More
- An overview of the medical device regulations in the Kingdom of Saudi Arabia 9th May 2025 - Stay compliant in the Saudi market: gain essential insights into classification, registration, and post-market requirements under the SFDA's medical device regulations Read More
- MDSAP: A comprehensive review of its impact, implementation, and future in global regulatory harmonisation 9th May 2025 - Understand how MDSAP streamlines global compliance: explore its audit approach, stakeholder benefits, and key implementation challenges in this in-depth review Read More
- An overview of the regulatory requirements for medical devices and IVDs in Botswana 9th May 2025 - Navigate Botswana’s evolving regulatory landscape: key insights into classification, registration pathways, and compliance for medical devices and IVDs Read More
- May 2025 – Volume 22, Issue 2 30th April 2025 - Snapshot of the May 2025 issue of the Journal of Medical Device Regulation: AI Act: The many ambiguities of the European Union’s Artificial Intelligence Act Saudi Arabia: An overview of the medical device regulations in the Kingdom of Saudi Arabia… Read More
- Michael S. Heyl Joins the Editorial Board of the Journal of Medical Device Regulation 1st April 2025 - The Journal of Medical Device Regulation (JMDR) is pleased to announce the appointment of Michael S. Heyl to its Editorial Advisory Board. A recognised expert in medical device regulation, Mike brings a wealth of knowledge and hands-on experience in navigating… Read More
- Free Podcast: What’s allowed – and what’s not – when marketing medical devices online? 25th March 2025 - 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… Read More
- High quality PMCF surveys under the EU MDR – from planning through to execution and data analysis 3rd March 2025 - Ensure your PMCF surveys meet your regulatory needs - practical insights on planning, execution, and data analysis to stay MDR compliant Read More
- A Notified Body’s perspectives on progress made in transitioning combination products to the MDR 10th February 2025 - Get exclusive insights from a Notified Body on the progress, challenges, and solutions for combination products transitioning to the MDR Read More
