Recent shifts within the U.S. FDA reflect an increasingly complex tension between scientific rigor and accelerating political ...

In medical device development, things don’t go quite as you planned the first time around. This article shares what to really ...

As the use of medical device software and software as a medical device (SaMD) grows, regulatory bodies around the world are ...

Regulatory information management (RIM) software tools streamline global regulatory processes on a single cloud-based platform for managing regulatory submissions, tracking registrations, and ...

Cardiovascular diseases are responsible for over 15 million deaths worldwide per year. 1 The occlusion of vessels such as the coronary or peripheral arteries hinders the flow of blood to the heart, ...

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 ...

All startups must navigate the “Valley of Death” as they transition from initial discovery and ideation to market launch. This critical period, characterized by heightened risk of failure, is ...

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 — ...

As a general matter, there are three common types of product liability claims: (1) manufacturing defect, (2) design defect, and (3) failure to warn. Each of these scenarios is premised upon a product ...

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 ...