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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
January 11, 2024

Demystifying FDA’s Pre-Market Final Guidance

FDA recently issued a final guidance on medical device cybersecurity emphasizing the importance of managing and mitigating cybersecurity risk throughout the total product lifecycle in addition to outlining FDA’s expectations for submission information to address cybersecurity concerns.

As a result, there have been many misconceptions and myths about the new requirements swirling around the MedTech industry.

Well, who better than the FDA itself to speak on this topic and set the record straight?

FDA's Jessica Wilkerson will present highlights and updates from the final pre-market guidance to help organizations be well prepared for the requirements.

The webinar will then continue with Jessica and medical device experts, Ken Zalevsky and Etienne Nichols discussing key findings. The audience will then be given an opportunity to participate with Q&A. 

Watch the webinar
Demystifying FDA’s Pre-Market Final Guidance - webinar graphic

Specifically, this webinar will cover:
  • Must-know key points about the final guidance
  • FDA's experiences and lessons learned so far
  • Cybersecurity highlights
  • Tips to achieve compliance and successful submissions
  • Audience Q&A
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
Ken Zalevsky
Presenter:
Ken Zalevsky

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

Medical Device Guru,
Greenlight Guru

FDA

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.

Greenlight Guru logo

About Greenlight Guru

Greenlight Guru is the leading connected, cloud-based platform purpose-built for MedTech companies. The end-to-end solution streamlines product development, quality management, and clinical data management by integrating cross-functional teams, processes, and data throughout the entire product lifecycle. 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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