51ÁÔÆæ

Click now to listen to 51ÁÔÆæ's Director of Regulatory Affairs, Jordan Elder, in this 51ÁÔÆæ Radio audio update: The European Parliament recently voted for a timeline extension to MDR regulation,...

Among the emerging topics of interest to the life science industry, quality culture, quality metrics, and data integrity are in the spotlight due to changes from the COVID-19 pandemic. Regulatory...

The pharmaceutical and biologics industry recently received updated FDA guidance on the use of Generally Accepted Scientific Knowledge (GASK) in regulatory submissions. The FDA guidance provides new examples of when...

In this soundbite from 51ÁÔÆæ Radio, Dr. Helin Raagel and Dr. Matthew Jorgensen from Nelson Labs explain why the Cytotoxicity test during a biocompatibility evaluation is the most important test...

Click now to listen to 51ÁÔÆæ's Susan Schniepp and Steven Lynn, in this 51ÁÔÆæ Radio audio update: Personalized Medicine Software as medical device (SaMD) continues to emerge in consumer products,...

The International Medical Device Regulation Forum (IMDRF) recently published updated cybersecurity guidance for the medical device industry. The medical device cybersecurity working groups at IMDRF have been busy lately, publishing...