FDA Regulation and Approval of Medical Device...

Heart failure (HF) affects more than 64 million individuals worldwide, and 20% to 30% of patients with HF and systolic dysfunction have cardiac dyssynchrony due to conduction system disease. JAMA Review author Mihail Chelu, MD, PhD, of Baylor College of Medicine discusses cardiac ...  Show more

In the US, approximately 66% of reproductive-aged women have at least 1 modifiable risk factor for adverse pregnancy outcomes. Authors and ob-gyns Kylie Cooper, MD, and Daniel Breitkopf, MD, both from the Mayo Clinic, discuss ways to reduce maternal morbidity and mortality and im ...  Show more

In this episode, we speak with Janeen Winnike, the Associate Dean for Student Affairs at Rosalind Franklin and a co-course director for the Pharmacy Law course at the university. We review some of the key points regarding federal and Illinois pharmacy law – a must-listen espec ...

Description:In this episode, Ellie Reynolds, Associate Director of Quality Assurance and Regulatory Affairs at Proxima Clinical Research, dives deep into the complexities of FDA submissions for medical devices. She sheds light on the nuances of different submission types, such as ...  Show more

Description:Dive into the enlightening world of FDA inspections with Etienne Nichols and Mike Drues. In this comprehensive episode, the duo decodes the essence of effective communication, the importance of managing expectations, and the art of proactive dialogue with the FDA. The ...  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