The U.S. Food and Drug Administration (FDA) is making a major change to how medical device quality systems are regulated. […]
QSR vs. QMSR: What Medical Device Companies Need to Know Read More »
As software becomes increasingly central to modern medical technology, its development must meet rigorous technical and regulatory standards. Whether it’s
From Code to Compliance: Software Development in the Medical Device Industry Read More »
For medical device manufacturers around the world — whether based in Europe, the Middle East, India, Australia, the UK, or
The integration of robotics into medical devices has entered a new phase of maturity. Once considered cutting-edge, robotic technologies are
The Rise of Robotics in MedTech: How to Stay Ahead of Regulatory Complexity Read More »
The integration of 3D printing—also known as additive manufacturing—into medical device development has opened up new possibilities for personalization, complexity,
3D-Printed Medical Devices and FDA 510(k) Clearance: A Strategic Perspective Read More »
In today’s globalized healthcare market, medical device manufacturers often find themselves balancing two of the most influential regulatory systems in
Understanding the Divide: Navigating EU MDR and FDA 510(k) Compliance Read More »
Artificial Intelligence (AI) and Machine Learning (ML) are rapidly transforming the medical device landscape—from diagnostics to personalized medicine and real-time
Navigating the Future: AI/ML in Medical Devices and Regulatory Affairs Read More »
