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 ...

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 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 ...

Many manufacturing execution system (MES) deployments still operate like it is 2005: a big install, disruptive upgrades, etc. Here's a clearer path forward. International Society for Pharmaceutical ...

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 GxP-regulated operations, compliance works best when it’s treated as a shared responsibility, not a siloed function. When IT, OT, and Quality teams operate with aligned goals and a unified data ...

Regulatory expectations are shifting quickly as FDA modernization efforts, evolving EU frameworks, and emerging AI-driven processes move toward greater alignment. Explore where those changes stand ...

For medical device manufacturers, PFAS is no longer just a materials consideration—it is a significant business risk. Navigating this challenge requires balancing patient-critical performance with a ...

The revision of ISO 10993-3 signals a significant shift in medical device safety, moving away from traditional animal testing of extracts toward a more robust framework of chemical characterization ...