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

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

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 ...

In this article, Fran DeGrazio lays out ways for biopharma companies developing and commercializing combination products and ...

Neuromodulation devices are used to manage conditions such as chronic pain, neurological disorders, epilepsy, and more. New ...

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 ...

Medical device makers face growing global pressure to eliminate PFAS. Embracing circular design and innovation offers a path to compliance, sustainability, and supply chain resilience.