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 ...
A devices FDA class fails to account for modern cyber exposure. Learn why software architecture and connectivity require ...
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, ...
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 ...
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 ...
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 ...
The U.S. Food and Drug Administration (FDA) has issued its much-anticipated final guidance on cybersecurity risk management in medical devices, effective June 2025. This document, titled ...
The FDA proposed on Feb. 22, 2022, an update to the Quality System Regulation 1 that was released in 1996. The proposal is to reference ISO 13485:2016 Medical devices — Quality management systems — ...
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