Demystifying FDA’s Pre-Market Final Guidance

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

Hosted by

Presenter:
Jessica Wilkerson

Senior Cyber Policy Advisor & Medical Device Cybersecurity Team Lead,
FDA

Presenter:
Ken Zalevsky

CEO and Founder,
Vigilant Ops

Moderator:
Etienne Nichols

Medical Device Guru,
Greenlight Guru

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.

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.

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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