Bringing clarity to medical device regulatory professionals all over the world
- Global news updates – August 2025 12th August 2025 - Get the latest international regulatory news from the JMDR August 2025 issue - concise, expert-curated updates to keep you ahead in the medical device industry Read More
- An overview of the regulatory requirements for medical devices and IVDs in Uganda 12th August 2025 - Expand into Uganda: learn the regulatory requirements for medical devices and IVDs to navigate this emerging market with confidence Read More
- India’s regulatory framework for software as a medical device (SaMD) 12th August 2025 - Enter India’s SaMD market: understand the regulatory framework, approval process, and compliance essentials for software as a medical device Read More
- Overview of the regulatory requirements for medical devices in Switzerland 12th August 2025 - Stay compliant in Switzerland: gain a clear overview of the country’s current regulatory requirements for medical devices and how they impact market access Read More
- A comparative analysis of the US and EU performance-based regulatory pathways with recommendations for harmonisation 12th August 2025 - Compare and align: explore US and EU performance-based regulatory pathways for medical devices and discover practical recommendations for greater global harmonisation Read More
- August 2025 – Volume 22, Issue 3 1st August 2025 - Snapshot of the August 2025 issue of the Journal of Medical Device Regulation: SPBP vs MDR: A comparative analysis of the US and EU performance-based regulatory pathways with recommendations for harmonisation Switzerland: An overview of the regulatory requirements for medical… Read More
- FREE Podcast: The many ambiguities of the European Union’s Artificial Intelligence Act 28th July 2025 - 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… Read More
- 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
- 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
