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The USA/Canada Regulatory Knowledge Hub offers expert insight into medical device and IVD regulatory requirements across North America. Explore publications covering the US FDA and Health Canada frameworks, software and AI regulation, quality systems, post-market requirements, and key considerations for successful market access and compliance.
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
Best practices for obtaining breakthrough designation using the US FDA’s Breakthrough Devices Program
Discover how to strategically secure breakthrough device designation through proven approaches and practical insights from FDA experience Read More...
£50.00
Cybersecurity in the USA – developing a NIST SSDF-based Profile for low and moderate risk medical device applications
Strengthen cybersecurity compliance and apply the NIST SSDF framework to build secure, risk-appropriate development processes for medical device software Read More...
£50.00
A comparative analysis of the US and EU performance-based regulatory pathways with recommendations for harmonisation
Compare and align: explore US and EU performance-based regulatory pathways for medical devices and discover practical recommendations for greater global harmonisation Read More...
£45.00
Post-market surveillance and risk management – a comparison of the requirements in Europe and the USA
Harmonise your regulatory approach - compare EU and US PMS and risk management requirements to streamline your strategy and avoid costly missteps Read More...
£40.00
Social media and direct-to-consumer advertising of medical devices in the USA
What’s allowed - and what’s not - when marketing medical devices online? Ensure your social media and DTC ads stay FDA compliant. Read More...
£40.00
Canadian regulatory framework for software-based medical devices and emerging technologies
From SaMD to AI, Canada’s regulatory approach is evolving - understand what it means for your software-driven medical technologies Read More...
£40.00
US FDA finalises rule incorporating ISO 13485 into new Quality Management System Regulation (QMSR)
Understand the latest FDA rule changes and the integration of ISO 13485 into the QMSR, ensuring your medical device's QMS meets new regulatory standards Read More...
£35.00
