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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
October 3, 2024

How to Best Prepare for FDA QMSR

The FDA is moving from the Quality System Regulation (QSR) to the new Quality Management System Regulation (QMSR), aligning more closely with ISO 13485 standards.

If your organization isn’t prepared, you may face compliance challenges that could affect your business operations and market access.

Whether your organization is already ISO-certified or not, it’s vital to know how to adjust your systems to meet these new regulatory demands.

Join this free webinar, presented by our partner Emergo by UL, to learn how you can stay ahead of the upcoming QMSR changes. You'll gain expert insights and practical guidance to help you transition, as well as remain compliant and competitive in the market.

Specifically, this webinar will help you:
  • Gain clarity on QMSR and ISO 13485 differences: Understand the key distinctions between the two systems and how they will impact your compliance strategy.
  • Tailored preparation for your organization: Learn how to approach QMSR readiness based on whether or not your organization is currently ISO-certified.
  • Next steps for compliance: Get actionable insights on the specific steps your organization needs to take to prepare for the regulatory shift.
  • Build an effective quality plan: Learn how to create a robust quality plan that aligns with QMSR requirements and ensures timely compliance.

Watch the webinar
How to Best Prepare for FDA QMSR
Who should attend?
  • Quality Professionals and Management
  • Regulatory Affairs Professionals & Management
  • Medical Device Executives
Register Now  

Presented by

Vernon Baker
Moderator:
Vernon Baker

Senior Medical Device Guru,
Greenlight Guru
Luana Zerafa
Presenter:
Luana Zerafa

Program Manager QA/RA,
Emergo by UL

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Emergo by UL is a leading consulting firm specializing in global regulatory compliance and human factors for products in the medical and pharmaceutical industry. Our comprehensive services are designed to help you achieve and maintain regulatory and commercial success.

Visit their website to learn more.

Greenlight Guru logo

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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