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 ...

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 ...

Product labels that appear on device packages, admittedly, are not the most exciting part of medical device product design and development. They lack the excitement of scientific discovery, the cachet ...

Part 1 of this series presented factors that medical device developers should consider when executing HFE studies internally, detailing how to overcome obstacles while acknowledging that executing ...

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 ...

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 ...

Device functionality testing is an essential element of any medical device or drug delivery device development process. It is an essential part of design verification that demonstrates the developed ...

The European Union’s Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746) impose stringent requirements on all economic operators involved in the supply chain of ...

Heightened awareness about cybersecurity issues has led regulatory agencies and customers alike to demand security and high quality from medical devices. An effective way to protect medical devices ...

This article discusses why Colombia, despite the global effects of the COVID-19 pandemic, has become the country with the best commercial advantages in South America and one of the three best in Latin ...