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.

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 ...

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 ...

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 ...

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 ...

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 ...

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 ...

NovaPure components are West’s premium line of components developed and refined to provide the market with best-in-class levels of quality, performance, and risk mitigation. The brand includes ...

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 ...