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.

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 ...

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 ...

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 ...

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 ...

Ophthalmic medical devices address significant global health needs, as over 2.2 billion people face vision impairment, much of which is preventable or treatable. These devices range from low-risk ...

Cryostorage bags are critical for preserving biologics and cellular therapies, yet their reliance on fusion-sealed seams and ports creates inherent vulnerabilities. When these containers are exposed ...

Specialty Coating Systems (SCS) offers a variety medical coatings and technologies to support a range of medical device applications, including elastomeric seals, forming mandrels, pacemaker ...

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 ...