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.

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 ...

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 ...

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

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