This position paper clearly and concisely presents the view of Notified Bodies on positive elements and on major concerns with the...

Intertek Business Assurance will be at RAPS Convergence 2025 in Pittsburgh from October 7–9. Visit us at Booth 636! The Regulatory...

Artificial Intelligence is revolutionizing healthcare—from AI-powered diagnostics and robotic surgery to personalized treatment plans....

As the global medical device industry evolves, so too do the challenges—and opportunities—of expanding into new markets. Whether you're a...

The South African Health Products Regulatory Authority (SAHPRA) has given plenty of notice to industry over the last several years...

A groundbreaking artificial intelligence (AI) model developed by researchers at Case Western Reserve University is poised to transform...

Understanding ISO 13485 – Made Simple If you're in the medical device industry, you've probably heard of ISO 13485. But what exactly is...

The future of healthcare is shifting toward a more seamless and proactive approach, largely driven by advancements in technology and...

In a groundbreaking development, Dexcom has become the first medical device company to integrate generative AI into a continuous glucose...

Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) opening an office in Washington, DC is such interesting news. Stakeholders in...

Digital transformation has swept through all aspects of the world over the past few decades, connecting many devices and systems. While...

I’ve been in the industry for many years and have heard countless times about global harmonization and regulatory convergence. However,...