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More than a Quality Management System: Tools for the entire MedTech Lifecycle.

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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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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
September 7, 2023

Busting Mythconceptions about FDA’s Refuse-to-Accept Policy for Cybersecurity

In the dynamic landscape of medical device development, staying informed about regulatory changes is crucial. 

The FDA's 2022 draft premarket cybersecurity guidance and the updated Refuse to Accept (RTA) policy have introduced new considerations for medical device submissions. However, these changes have also given rise to various misconceptions and myths surrounding the FDA's cybersecurity requirements. 

If you’re submitting a 510(k), IDE, or de novo device submission to the FDA before, on, or after October 1, 2023, then this webinar is for you. 

Reasonable assurance for medical device security is no longer optional, and neither is buying into the mythconceptions swirling around our industry. 

Join Velentium’s Director of Product Security, Garrett Schumacher, for an engaging and informative session on complying with modern FDA cybersecurity regulations.

By the end of the webinar, participants will be equipped with valuable knowledge and actionable insights to confidently navigate the complexities of FDA cybersecurity requirements and enhance their medical device submission strategies.

Watch the webinar
Busting Mythconceptions about FDA’s Refuse-to-Accept Policy for Cybersecurity
Specifically, this webinar will provide:
  • Clear Understanding of FDA Cybersecurity Guidance: Participants will gain a comprehensive grasp of the FDA's 2022 draft premarket cybersecurity guidance, including its implications for medical device submissions. This knowledge will enable them to navigate the regulatory landscape with confidence. 
  • Myth-Busting and Accurate Information: Attendees will have the opportunity to debunk prevalent myths and misconceptions surrounding FDA cybersecurity requirements. By separating fact from fiction, they can make informed decisions and avoid pitfalls that could hinder their submission process. 
  • Effective Compliance Strategies: Learn practical and actionable strategies to ensure reasonable assurance for medical device security in alignment with modern FDA regulations. These strategies will empower participants to proactively address cybersecurity challenges and meet regulatory expectations.
  • RTA Policy Navigation: Understand the updated Refuse to Accept (RTA) policy and gain insights into how to navigate the submission process seamlessly. Discover key steps to enhance submission readiness and increase the likelihood of a successful review.
  • Engaging Q&A Interaction: Engage in a dynamic Q&A session with our expert speaker, Garrett Schumacher. Participants can seek personalized insights, ask burning questions, and receive guidance tailored to their specific concerns, providing a unique opportunity for direct interaction and clarification.
Who should attend?
  • Regulatory Affairs Professionals & Management
  • Quality Professionals and Management
  • Medical Device Executives
  • Product Development Engineers and Management
  • R&D Engineers and Management
  • Medical Device Security
Register Now  

Hosted by

Etienne-Nichols-round
Moderator:
Etienne Nichols

Medical Device Guru,
Greenlight Guru
Garrett Schumacher
Presenter:
Garrett Schumacher

Director of Product Security,
Velentium

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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 Velentium

Velentium is a Houston-based professional engineering firm specializing in the end-to-end design, development, manufacturing and post-market support of therapeutic and diagnostic active medical devices. Velentium’s Product Security Team serves their clients by augmenting their workforces with breadth and depth of knowledge and expertise to solve their cybersecurity challenges with the right-sized solutions. We can improve both the end user and the manufacturer experience by implementing robust cybersecurity measures into our clients’ organizations, their personnel, and their products. 

Visit their website to learn more.

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