Regulatory Requirements for Medical Device Manufacturing and Quality System (QS) Regulation: An Introduction
A session from FDLI’s Introduction to Medical Device Law and Regulation
Recorded April 9, 2025
Regulatory Requirements for Medical Device Manufacturing and Quality System (QS) Regulation: An Introduction
Identify the background, purpose, and regulatory requirements of the Quality System Regulation. Learn key requirements of the QS Regulation. Understand why and how to mitigate QS Regulation noncompliance.
Amy Leiser, Special Counsel, Regulatory Affairs, Covington & Burling LLP
Cynthia Culmo, Senior Advisor, Covington & Burling LLP
This session was recorded as part of FDLI’s Virtual Introduction to Medical Device Law and Regulation Course in April 2025.
AMY LEISER is Special Counsel in the Food, Drug & Device group at Covington & Burling LLP in San Francisco, CA. With a focus on medical device, digital health, and diagnostic products and laboratory services, Amy regularly advises and advocates on behalf of clients on a variety of federal and state regulatory, legislative, and compliance matters. In her work with both new and established companies, Ms. Leiser regularly counsels clients on the full life cycle of devices and diagnostic services, including development and marketing strategies for products, compliance with medical device postmarketing requirements, and responding to domestic and international enforcement actions. She also regularly supports life sciences transactions, including through regulatory diligence for investments and acquisitions, as well as negotiation of collaboration agreements.
CYNTHIA CULMO is a Senior Advisor at Covington & Burling. She’s licensed pharmacist with 30+ years’ experience across global, FDA and State regulatory enforcement, quality and compliance in manufacturing and distribution, enforcement and industry management and leadership roles in medical products, including medical devices, biologics, and pharmaceuticals. She has extensive experience with strategy, coordination, and management of FDA, global agencies and Notified Third Body inspections. She provided support for industry readiness, inspection support, and remediation of quality systems. This includes successfully addressing Consent Decrees, Warning and Untitled Letters and 483 responses. Additionally, Cynthia has 30+ years’ experience as AFDO’s delegate to the US Pharmacopeia, serving as member of the USP Governance Committee, and several USP expert committees and subcommittees.Get Access
-
$100 for nonmembers
Internet Explorer and Microsoft Edge are not supported by the checkout process.
Please use Chrome, Firefox, or Safari. If you are unable to use these browsers, please contact us at 202-371-1420 or [email protected] and we will assist you.
Virtual Learning FAQ
Related Content
