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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
April 3, 2024

Live Q&A with FDA: Cybersecurity Premarket Guidance

After the success of our recent webinar with FDA, Demystifying FDA’s Pre-market Final Guidance, we realized the conversation was just getting started. 

That's why we're excited to announce our exclusive follow-up event - and this time we’re adding more FDA representation.

Join us as FDA’s Jessica Wilkerson and Matthew Hazelett address more unanswered questions and provide the latest updates and insights on the final guidance document, Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions.

Don't miss this opportunity to interact directly with FDA and gain clarity on the final guidance. Register now and be part of a pivotal discussion that can shape your approach to medical device cybersecurity.

Why you should attend this webinar:
  • Unanswered Questions, Addressed: We know many of you left our last session with questions still buzzing in your mind. FDA is back, ready to delve into the unanswered questions.
  • Interactive Discussion: This live, interactive session is your opportunity to engage directly with FDA cybersecurity experts. Bring your questions and prepare for a dynamic discussion.
  • Stay Ahead with the Latest Insights: Hear valuable insights and experiences straight from FDA and industry leaders.
  • Beyond the Guidance: Learn about new developments and findings following the final guidance release in 2023 that could impact your strategies.

Watch the webinar
Live Q&A with FDA Cybersecurity Premarket Guidance-1
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

Jessica Wilkerson
Presenter:
Jessica Wilkerson

Senior Cyber Policy Advisor & Medical Device Cybersecurity Team Lead,
FDA
Matthew Hazelett
Presenter:
Matthew Hazelett

Cybersecurity Policy Analyst,
FDA
Ken Zalevsky
Presenter:
Ken Zalevsky

CEO and Founder,
Vigilant Ops
Etienne-Nichols-round
Moderator:
Etienne Nichols

Medical Device Guru,
Greenlight Guru

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About FDA CDRH

In keeping with our mission, the Center for Devices and Radiological Health (CDRH) is responsible for protecting and promoting the public health. We assure that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products. We provide consumers, patients, their caregivers, and providers with understandable and accessible science-based information about the products we oversee. We facilitate medical device innovation by advancing regulatory science, providing industry with predictable, consistent, transparent, and efficient regulatory pathways, and assuring consumer confidence in devices marketed in the U.S.
We seek to continually improve our effectiveness in fulfilling our mission by planning strategically and regularly monitoring our progress.

Visit their website to learn more.

VigilantOps

About Vigilant Ops
Founded in 2019 by medical device cybersecurity veterans, Vigilant Ops is the leading SBOM management, intelligence, and exchange platform used by regulated organizations that build and buy medical devices and software. Vigilant Ops simplifies the SBOM journey with real-world experience forged in the most rigorously regulated industries. Generate, manage and securely share your SBOMs in a single end-to-end platform.

Visit their website to learn more.

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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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