While Mexicos health authority, COFEPRIS, has streamlined registration for medical devices, a dangerous shadow regulation has ...

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 ...

A devices FDA class fails to account for modern cyber exposure. Learn why software architecture and connectivity require ...

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 ...

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

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 ...

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 ...

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 ...

Each clause contains the requirements as well as sub-clauses, which support the main clause by providing the details of the standard’s requirements for a QMS. For the purposes of this article, 21 CFR ...

Colombia has a population of approximately 50 million inhabitants, making it the third most populous country in Latin America after Mexico and Brazil. 1 Colombia's economy is the fourth-largest by ...

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 — ...