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 ...

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

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.

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 ...

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 ...

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

Periodically, standards are revisited by international and national committees to determine if they are still current or need revision or withdrawal. Through the voting process and based on comments ...