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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
November 9, 2023

Demonstrating Conformity to General Safety and Performance Requirements (GSPR) under MDR

Are you preparing to upgrade your device technical documentation to meet the European Union’s Medical Device Regulation (MDR) 2017/745 General Safety and Performance Requirements (GSPR)?

Having a strong understanding of the differences between the essential requirements of the Medical Device Directive (MDD) and the GSPR of the MDR is critical to demonstrating conformity to the applicable requirements.

Register for this free, in-depth webinar, presented by EU regulatory expert Rachel Paul-Zieger from Emergo by UL, to gain valuable insights and actionable tips on how to demonstrate compliance to the MDR for GSPR.

Watch the webinar
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Specifically, this webinar will cover:
  • Overview of essential requirements under MDD vs. GSPR under MDR
  • How to demonstrate compliance to the MDR for GSPR
  • Actionable tips for drafting a GSPR checklist
  • The hierarchy between methods to demonstrate compliance between the standards and the common specifications and the manufacturer's testing methods
Who should attend?
  • Regulatory Affairs Professionals & Management
  • Quality Professionals and Management
  • Medical Device Executives
Register Now  

Hosted by

Laura-Maher
Moderator:
Laura Maher

Medical Device Guru,
Greenlight Guru
Rachel Paul-Zieger Emergo
Presenter:
Rachel Paul-Zieger

Lead Quality and Regulatory Affairs Consultant,
Emergo by UL

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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 Emergo by UL

Emergo by UL develops customized regulatory strategies that leverage your existing registrations and can support expanding your global market reach, whether for one or several products.

Leveraging more than 22 years of regulatory experience, we developed the Regulatory Affairs Management Suite (RAMS) digital  platform, which enables regulatory research and more.

Visit their website to learn more.

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