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

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 ...

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

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

Package integrity can be defined as a package’s ability to prevent product loss, maintain product sterility, and in some cases, prevent oxygen ingress or maintain sub-atmosphere headspace pressures.

Developments in non-destructive, deterministic testing technologies that can achieve optimum assurance in container closure integrity. When assuring the quality of all packaged products, testing ...

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 ...

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 ...

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, ...