Autoinjectors add mechanical forces and interactions that change how container closure integrity must be evaluated. Learn why device complexity creates new risks and how testing strategies must adapt.

While Mexicos health authority, COFEPRIS, has streamlined registration for medical devices, a dangerous shadow regulation has emerged with ad hoc stringent cybersecurity requirements.

In launching this key offering, Eurofins Medical Device Consulting marks an inflection point for its Medical Device, Combination Product, and Diagnostic service portfolio – moving from testing ...

Ethylene oxide sterilization is transforming. Manufacturers must adopt risk-based approaches and optimized cycles to meet rigorous emission controls and patient safety limits for sensitive populations ...

Within the EU's regulations, Article 10(9) refers to quality system requirements under Annex IX. This is a specific requirement concerning quality control for the devices that use AI technology under ...

In 2023, the FDA made the electronic Submission Template And Resource (eSTAR) mandatory for most 510(k) submissions. Although eSTAR is not an AI tool, the move was the first definitive leap toward the ...

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 ...

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 ...

Artificial intelligence (AI) and machine learning (ML) are redefining healthcare, from enabling earlier diagnoses and personalized treatments to streamlining hospital operations and accelerating ...