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 ...

Neuromodulation devices are revolutionizing the treatment of neurological disorders by modulating nervous system activity through targeted electrical stimulation. These devices are used to manage ...

China’s medical device market is at an inflection point. According to Statista, the market has a projected CAGR of 8% and is expected to surpass $55.67 billion by 2029, positioning China as the second ...

The medical device industry is under increasing pressure to address environmental and health concerns linked to per- and polyfluoroalkyl substances (PFAS). These “forever chemicals” are widely used in ...

Qualification, and demonstration of fit-for-purpose, for a drug product vial/stopper/seal primary package system comprises many factors: protection, compatibility, safety, and performance. One of the ...

Software- Clinical Operations departments are responsible for the design, development, and review of clinical trial protocols, monitoring and tracking the execution of clinical trials, and ensuring ...