Expert e-publications covering the EU MDR/IVDR, clinical evaluation, regulation of software and AI, environmental issues, combination products, and global market access.
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Trending topics: MDR/IVDR Clinical Software/AI/Digital Health Environment Combinations/Borderlines
Newly added publications
The impact of halal certification on market access for medical devices in Indonesia – A comprehensive guide for global medical device and IVD manufacturers
Understand Indonesia's halal product assurance requirements for medical devices and IVDs, including certification pathways, exemption criteria, and quality management considerations Read More...
£69.00
Proposed MDR/IVDR amendments in practice: operational implications for manufacturers
A practical examination of the proposed December 2025 MDR/IVDR amendments and their implications for lifecycle oversight and manufacturer regulatory operations Read More...
£69.00
An overview of the medical device regulations in the Arab Republic of Egypt
A comprehensive guide to navigating Egypt's evolving medical device regulatory landscape Read More...
£69.00
A framework for pre-submission risk screening in medical device regulatory submissions: categorising common FDA deficiency themes
Learn how a structured framework of 24 common FDA deficiency themes can support more effective pre-submission review for 510(k), PMA, and De Novo applications Read More...
£69.00
Regulatory Monitor – updating you on legislative changes
Get the latest international regulatory updates from the JMDR August 2026 issue – concise, expert-curated updates to keep you ahead in the medical device industry Read More...
£145.00
Regulatory divergence of NIRS-based technologies: distinguishing cerebral oximeters and fNIRS devices under international 80601 standards
Understand how evolving international standards distinguish cerebral oximeters from fNIRS devices and the implications for regulatory submissions and device classification Read More...
£0.00
Regulatory Intelligence Pack: AI in MedTech
AI-enabled medical devices are now firmly in scope of multiple regulatory frameworks. This Regulatory Intelligence Pack provides a curated set of high-impact AI insights, designed to offer you clarity and practical considerations. Read More...
£149.00
Regulatory Intelligence Pack: Middle East & Africa
Expanding into emerging markets requires reliable, practical information that’s often hard to access - this Regulatory Intelligence Pack provides country overviews of key Middle East and African markets Read More...
£235.00
