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

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

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

Government-led industrial policies and rapid technological advancements are reshaping market dynamics for medical devices in ...

As the timeline for commercialization closes in, it’s necessary to best position the organization for a successful launch.

Effective sterilization is vital in pharma and medical device manufacturing. Discover how the Bowie-Dick test ensures vacuum ...

Medical device makers face growing global pressure to eliminate PFAS. Embracing circular design and innovation offers a path ...

Discover why biological indicators are the gold standard for sterilization validation in pharmaceutical and medical device ...

Recent U.S. elections and President Donald Trump’s new appointments have drawn global attention. Entire industries and nations brace for potential changes in their trade relationships with the world’s ...

With the rise AI-enabled medical devices, the FDA is soliciting comments and feedback regarding the importance of AI safety and effectiveness considerations in advance of its upcoming Digital Health ...

ISO 14971 is one of the most referenced and quoted risk analysis guidance documents in the medical device industry. 1 The guidance’s influence sometimes extends well beyond just medical devices. The ...