FDA warning letters highlight recurring patterns, systemic gaps, and evolving priorities that medical device manufacturers ...

This article explains why Latin Americas demographic diversity, cost profile, and accelerating digital health infrastructure ...

Early recognition and mitigation of drug and device integration difficulties are critical to the success of combination ...

This article describes how a mechanism-based risk analysis approach can provide two complementary opportunities for ...

In the pharma/biotech and medical device industries, the audit trail is important to have for accountability, data integrity, repeatability to create an event for investigation, and regulatory ...

The digital revolution that resulted in the IoT, IoMT, SaMD, and connected devices comes with the possibility of cyberattacks. The FDAs latest efforts to enhance medical device cybersecurity include a ...

Polymer physics and mechanical engineering principles contribute significantly to the advancement of percutaneous transluminal coronary angioplasty (PTCA) and balloon catheter expansion. This article ...

Colombia has a population of approximately 50 million inhabitants, making it the third most populous country in Latin America after Mexico and Brazil. This article covers the general Colombian health ...

The FDAs proposed update to the Quality System Regulation that was originally released in 1996 references ISO 13485:2016 Medical devices — Quality management systems — Requirements for ...

The EU Regulation 745/2017 on medical devices (EU MDR) lists in Annex XVI several beauty devices that the EU Commission wants to regulate as medical devices, including colored contact lenses, cosmetic ...