March 20, 2024

QMSR Final Rule: Meeting FDA’s New Requirements

On 2 February 2024, FDA finalized revisions to the Quality System Regulation (QSR) harmonizing it to the international medical device standard ISO 13485:2016 under the new title Quality Management System Regulation (QMSR). The final rule becomes effective 2 February 2026.

This webinar provides background to the action taken by FDA, an overview of the final rule, how FDA responded to comments made to the proposed rule, and how it may impact both the MedTech industry and FDA. Particular emphasis will be placed on risk management, transition issues, and FDA inspections.

Specifically, this webinar will cover:
  • Why ISO 13485 and why now?
  • The meaning of "incorporation by reference"
  • Step-by-step walk through of the new 21 CFR Part 820 (QMSR)
  • Impacts of the final rule on combination products
  • How risk management changes under the QMSR
  • Considerations during the two-year transition period
  • Clarification regarding FDA inspections under the final rule

Watch the webinar

QMSR Final Rule- Meeting FDA’s New Requirements
Who should attend?
  • Regulatory Affairs Professionals & Management
  • Quality Professionals and Management
  • Medical Device Executives
  • Product Development Engineers and Management
  • R&D Engineers and Management
Register Now  

Hosted by

Etienne Nichols

Medical Device Guru,
Greenlight Guru

Eric Henry round
Eric Henry

Sr. Quality Systems and Compliance Advisor,
King & Spalding LLP

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About Greenlight Guru

Greenlight Guru is the leading cloud-based platform purpose-built for MedTech companies. The end-to-end solution goes beyond traditional QMS needs by integrating cross-functional teams, processes, and data throughout the entire product lifecycle so device makers can proactively overcome execution gaps, streamline compliance, and accelerate market success.

Greenlight Guru’s platform is used by organizations across the globe that are replacing their disjointed, legacy tools and solutions to bring life-changing products to people faster, and with less risk.

Visit our homepage to learn more.

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About King & Spalding LLC

Celebrating more than 130 years of service, King & Spalding is an international law firm that represents a broad array of clients, including half of the Fortune Global 100, with 1,300 lawyers in 23 offices in the United States, Europe, the Middle East and Asia. The firm has handled matters in over 160 countries on six continents and is consistently recognized for the results it obtains, uncompromising commitment to quality, and dedication to understanding the business and culture of its clients.

Our FDA and Life Sciences team guides companies regulated by the FDA, including in pharmaceuticals, biotech, devices, food, supplements, cosmetics. and tobacco, through all aspects of U.S. and EU regulatory compliance challenges. We draw on years of industry experience to work through every issue at every stage of a product’s life cycle.

Manufacturers, investors, and other regulated entities value our practical advice and relationships with U.S. state, federal and EU regulatory bodies. The team’s 40+ lawyers and consultants have held senior positions in government, industry, academia and the medical profession.

Visit their website to learn more.

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