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 ...

D-values are essential for ensuring sterility in pharma and medical device manufacturing. Explore a simplified concept that ...

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

Sterilization validation is vital in pharma and medical device manufacturing to ensure product safety and regulatory ...

Connected drug delivery devices integrate digital connectivity — often via Bluetooth — with traditional drug administration ...

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, ...

The FDA proposed on Feb. 22, 2022, an update to the Quality System Regulation 1 that was released in 1996. The proposal is to reference ISO 13485:2016 Medical devices — Quality management systems — ...

This is the second article in our three-part article series on postmarket change controls and implementing a Predetermined Change Control Plan (PCCP) for Class II Software as a Medical Device (SaMD) ...

When developing combination products or evaluating primary packaging for drug products one must evaluate the performance of ...