FDA Regulation and Approval of Medical Device...

Circulating tumor DNA (ctDNA)(liquid biopsies) can help monitor cancer progression, detect residual cancer after treatment, and identify genetic changes within cancer cells that could affect treatment response. Author Ben Ho Park, MD, PhD, of the Vanderbilt-Ingram Cancer Center d ...  Show more

Physical activity is an effective component of care for people with chronic medical conditions. In this podcast, JAMA Insights author Alessio Bricca, PhD, University of Southern Denmark, discusses adaptable methods to promote physical activity in patients with chronic medical con ...  Show more

In this episode of the Global Medical Device Podcast, Etienne Nichols and regulatory consultant Mike Drues delve into the often-overlooked yet critical topic of device descriptions in FDA submissions. Discover why this foundational element can determine the success of your regula ...  Show more

If you're like many in the medical device industry, you've probably had some questions at one time or another around the FDA's Design Control Guidance. And if you're anything like the guests on today's podcast, you've probably gone through a lot of trial and error trying to imple ...  Show more

FDA has proposed a new rule to align its Quality System Regulation (QSR) with ISO 13485:2016, the international standard for medical device quality management systems. How will, what's being referred to as Quality Management System Regulation (QMSR), affect the medical device ind ...  Show more

Description:In this episode of the Global Medical Device podcast, we discuss the intricate world of medical device regulations, design, and innovation. Hosted live in San Jose, the podcast features the esteemed Nada Hanafi, SVP - Regulatory Strategy at Veranex, who brings her ric ...  Show more