The FDA released their updated guidance on Cybersecurity in medical devices: Quality System Considerations and content for Premarket submissions at the end of June in 2025. In this guidance the FDA ...

In the midst of a global pandemic in which thousands of people are losing their lives daily and we have no idea what the next week will bring, pondering the long-term risk implications for your agency ...

Moderator: Kara Lowe, Chief Operating Officer, KC Tech Council — As chief operating officer, Kara Lowe manages KC Tech Council’s relationships with investors, representing 150+ companies throughout ...

Julia Kagan is a financial/consumer journalist and former senior editor, personal finance, of Investopedia. Chip Stapleton is a Series 7 and Series 66 license holder, CFA Level 1 exam holder, and ...

With the growth of automation and increase of workers engaging with machines, I felt there would be some benefit to sharing an example of the safety risk assessments that we do in order to reduce or ...

This article describes a new, combined, quantitative method for assessing excipient risks that has been developed by the authors as one possible risk evaluation method. According to the modern ...