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More than a Quality Management System: Tools for the entire MedTech Lifecycle.

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Featured Capabilities:

Document Management Training Management Product Development Design Control Risk Management CAPA Management Audit Management

Experience the #1 QMS software for medical device companies first-hand. Click through an interactive demo.

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Data collection and management designed for MedTech clinical trials.

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Featured Capabilities:

Electronic Data Capture (EDC) Electronic Case Report Forms (eCRF) Electronic Patient Reported Outcomes (ePRO) Ad-Hoc Data Collection (Cases) Post-Market Surveys Product Add-Ons

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Ultimate Guide to Comparing Quality Management System Solutions

This eBook compares the best QMS software solutions to help medical device companies make an informed decision when investing in a quality management system.

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FREE ON-DEMAND WEBINAR
September 28, 2023

QSR to QMSR: The Rewrite of 21 CFR Part 820 & Key Considerations for FDA Compliance

FDA is replacing the existing Quality System Regulation (QSR) with a Quality Management System Regulation (QMSR) as a rewrite of 21 CFR Part 820 and a revision of relevant sections of 21 CFR Part 4 (Combination Products). 

The QMSR will align U.S. medical device regulations with ISO 13485:2016 and was submitted as a proposed rule on 24 May 2022.

Register for this informative and engaging webinar where FDA regulatory expert Eric Henry will provide an overview of the QMSR proposed rule, explain next steps in the rulemaking and implementation process, and discuss important considerations for medical device manufacturers. 

There will be time allotted for Q&A and to discuss impacts to both industry and the FDA, as a result of this significant regulatory change.

Register for the webinar
GG King & Spalding 9-28-23 Webinar_v2
Specifically, this webinar will cover:
  • What is happening to the QSR and how ISO 13485 fits into the regulatory picture
  • The meaning of "incorporate by reference"
  • Important concepts of interest from the proposed rule 
  • Next steps in the rulemaking and rollout of the QMSR 
  • Impacts of the QMSR to both industry and FDA
Who should attend?
  • Regulatory Affairs Professionals & Management
  • Quality Professionals and Management
  • Medical Device Executives
Register Now  

Hosted by

Etienne-Nichols-round
Moderator:
Etienne Nichols

Medical Device Guru,
Greenlight Guru
Eric Henry round
Presenter:
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

The FDA and Life Sciences team at King & Spalding LLC 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. They 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 their 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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