<p>In this episode, Health+Tech hosts Kristen McDermott Woodrum and Allyson Maur sit down with Compliance Architects’ Teresa Gorecki and Ricki Chase to discuss the FDA’s new Quality Management System Regulation (QMSR) and explore how medical device and health tech companies should reevaluate their risk management.</p>

In this episode, Health+Tech hosts Kristen McDermott Woodrum and Allyson Maur sit down with Compliance Architects’ Teresa Gorecki and Ricki Chase to discuss the FDA’s new Quality Management System Regulation (QMSR) and explore how medical device and health tech companies should reevaluate their risk management.

From Software to Scrutiny: Navigating FDA Inspections Under the New QMSR

Welcome to Health+Tech — Our podcast explores issues and trends at the intersection of healthcare, technology and innovation The podcast is presented by the firm’s Digital Health, Technology and Innovation Group, which helps clients navigate transactional, regulatory and compliance challenges in areas such as telehealth, data privacy and security, and health information technology.

McGuireWoods is a full-service firm providing legal and public affairs solutions to corporate, individual, and nonprofit clients worldwide for more than 200 years collectively. Our commitment to excellence in everything we do gives our clients a competitive edge in everything they do. Our law firm, over its 186-year history, has earned the loyalty of our many long-standing clients with a deep understanding of their businesses, and broad skills in corporate transactions, high-stakes disputes, and complex regulatory and compliance matters.

To learn more about McGuireWoods or to contact us, please visit our website at mcguirewoods.com.

This podcast was recorded and is being made available by McGuireWoods for informational purposes only. By accessing this podcast, you acknowledge that McGuireWoods makes no warranty, guarantee, or representation as to the accuracy or sufficiency of the information featured in the podcast. The views, information, or opinions expressed during this podcast series are solely those of the individuals involved and do not necessarily reflect those of McGuireWoods. This podcast should not be used as a substitute for competent legal advice from a licensed professional attorney in your state and should not be construed as an offer to make or consider any investment or course of action.

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Welcome to Health+Tech — Our podcast explores issues and trends at the intersection of healthcare, technology and innovation The podcast is presented by the firm’s Digital Health, Technology and Innovation Group, which helps clients navigate transactional, regulatory and compliance challenges in areas such as telehealth, data privacy and security, and health information technology. McGuireWoods is a full-service firm providing legal and public affairs solutions to corporate, individual, and nonprofit clients worldwide for more than 200 years collectively. Our commitment to excellence in everything we do gives our clients a competitive edge in everything they do. Our law firm, over its 186-year history, has earned the loyalty of our many long-standing clients with a deep understanding of their businesses, and broad skills in corporate transactions, high-stakes disputes, and complex regulatory and compliance matters. To learn more about McGuireWoods or to contact us, please visit our website at mcguirewoods.com. This podcast was recorded and is being made available by McGuireWoods for informational purposes only. By accessing this podcast, you acknowledge that McGuireWoods makes no warranty, guarantee, or representation as to the accuracy or sufficiency of the information featured in the podcast. The views, information, or opinions expressed during this podcast series are solely those of the individuals involved and do not necessarily reflect those of McGuireWoods. This podcast should not be used as a substitute for competent legal advice from a licensed professional attorney in your state and should not be construed as an offer to make or consider any investment or course of action.

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From Software to Scrutiny: Navigating FDA Inspections Under the New QMSR

From Software to Scrutiny: Navigating FDA Inspections Under the New QMSR