QMSR: The Future of FDA's Quality Management ...

The FDA's new Quality Management System Regulation (QMSR), which replaces the 21 CFR Part 820 Quality System Regulation (QSR) and incorporates ISO 13485:2016 by reference, represents a significant harmonization effort in the medical device industry. While viewed by some as a mere ...  Show more

The MedTech talent landscape has undergone a significant "reset" in the two years since Elena Kyria, founder and CEO of Elemed, last joined the podcast. Driven by factors like the rise of AI, economic volatility, and post-pandemic shifts, the dynamic has swung from a "war for tal ...  Show more

Rules for the regulation of medical devices, such as hip prostheses and implantable defibrillators, are complex and differ from those for drugs. Aaron Kesselheim, MD, JD, MPH, and Jonathan Darrow, SJD, LLM, JD, MBA, both faculty members in the Division of Pharmacoepidemiology ...

An interview with Dr. Paul Celano from the Greater Baltimore Medical Center on the recently published ASCO Standards on safe handling of hazardous drugs. The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not int ...  Show more

WEGO Health is on a mission-driven company connecting healthcare with the experience, skills, and insights of Patient Leaders. They are the world’s largest network of Patient Leaders, working across virtually all health conditions and topics. The WeGo Health network collaborates ...  Show more

According to WHO, the global cost associated with medication errors is 42 billion US dollars. Errors can happen at the point of prescribing, transcribing from one system to the other, or administration, when the wrong patient is given either the wrong drug or the wrong dose. Medi ...  Show more