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 ...

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.

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 digital revolution that resulted in the Internet of Things (IoT), Internet of Medical Things (IoMT), Software as a Medical Device (SaMD), and connected devices permeating the healthcare ...

Artificial intelligence (AI) and machine learning (ML) are redefining healthcare, from enabling earlier diagnoses and personalized treatments to streamlining hospital operations and accelerating ...

Periodically, standards are revisited by international and national committees to determine if they are still current or need revision or withdrawal. Through the voting process and based on comments ...

AI-assisted symptom recognition and pattern matching leverages machine learning to analyze vast amounts of medical data, including patient histories, clinical notes, and research publications, to ...

SCS devices deliver electrical pulses to the spinal cord to relieve chronic pain. They are often used as treatment for failed back surgery syndrome, injuries to the spinal cord, complex regional pain ...