Stability studies measure how medical devices respond to environmental stresses such as temperature, humidity, light, and ...

Airborne ultrasound enables non-destructive seal monitoring, detecting subtle material variations. See how this proactive ...

The wearable medical device industry sits at the intersection of life sciences regulation and rapidly-evolving technology law. Companies in this space face overlapping legal frameworks that can ...

Navigating the evolving landscape of global regulations concerning Per- and Polyfluoroalkyl Substances (PFAS) in medical devices requires a proactive, comprehensive strategy. Manufacturers must ...

An FDA warning letter is more than a formal notice; it’s a visible sign that a company’s quality system has failed to meet critical expectations. Yet behind every warning letter lies a wealth of ...

The global medical device market is estimated to be currently about $680 billion and is projected to grow to over a trillion dollars within 10 years at a compound annual growth rate of 6%. 1 As the ...

The U.S. Food and Drug Administration (FDA) has issued its much-anticipated final guidance on cybersecurity risk management in medical devices, effective June 2025. This document, titled ...

In Part 1 of this series, I explored how countries across the globe are shaping regulatory frameworks to manage the rapid integration of artificial intelligence (AI) and machine learning (ML) in ...

AI-assisted symptom recognition and pattern matching leverages machine learning to analyze vast amounts of medical data, including patient histories, clinical notes, and research publications, to ...

In a year characterized by both unprecedented challenges and groundbreaking advancements, the medtech industry continues to demonstrate its resilience and capacity for innovation. Faced with the ...

The EU AI Act (Regulation (EU) 2024/1689) is a landmark legislation that will shape the future of AI in Europe and is expected to be the baseline for similar legislation in other countries/regions. It ...

Growing up in a family deeply rooted in medicine, I had a unique perspective on the field. My grandparents attended Meharry Medical College, and my parents met while studying at Howard University ...