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

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

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

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

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

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

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

Vertiva™ is an on-body delivery system platform composed of a single-use pod with pre-filled and pre-loaded cartridge and a multi-use, smart controller. The platform offers a wide range of performance ...

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 ...

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 — ...

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, ...

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) ...