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 ...

The FDA’s traditional classification system effectively labels a medical device’s clinical risk, but it is a poor predictor of how easily that same device can be hacked. While a Class III implantable ...

Ethylene oxide (EO) remains a foundational sterilization method for nearly half of all medical devices, particularly those with complex geometries or heat-sensitive materials. However, the industry is ...

As syringe-based products evolve toward higher viscosities and larger fill volumes, longstanding assumptions about dye ingress testing face growing mechanical constraints. Earlier analysis showed that ...

PFAS (per- and polyfluoroalkyl substances) are everywhere and medical device manufacturers are taking notice. With evolving global regulations and growing concerns about risk, understanding PFAS in ...