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

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 ...

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.

Selecting the right prefillable syringe (PFS) is a critical decision that directly impacts the interface between a drug and a patient. For emerging biotech companies, the traditional approach of ...

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 ...

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.

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 ...

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 ...

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 ...

The shift in ISO 10993-3 represents a fundamental change in how the industry approaches developmental and reproductive toxicity (DART). Rather than defaulting to exhaustive animal studies, the updated ...

Ensuring medical device safety requires a sophisticated understanding of how materials interact with human physiology. Modern biocompatibility assessments have shifted toward a rigorous risk-based ...