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 ...

A devices FDA class fails to account for modern cyber exposure. Learn why software architecture and connectivity require independent security assessments to protect patient data and ensure compliance.

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 ...

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 medical device industry has gone global, but most quality and regulatory leaders still operate with regional mindsets. We've mastered ISO 13485, understood CFR 820, and navigated EU MDR ...

Mesa PCDs (Process Challenge Devices) are innovative, patented tools specifically engineered to support the rigorous demands of ethylene oxide (EO) sterilization processes. These devices incorporate ...

Brazil's research capabilities are exemplified by several high-profile clinical studies that have achieved significant breakthroughs in medical device technology. The BrainGate-Brazil study at the ...

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 ...

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