Medical Device Cybersecurity: The Regulatory Landscape and How to Defend Your Practices During an Inspection – Webinar Recording/Transcript
Cybersecurity-related inspection practices are intensifying for devicemakers. If you don’t know how to defend cybersecurity during such an inspection, you need this presentation.
You’ll learn the FDA’s expectations for cybersecurity and how to craft your design control practices to execute and defend in compliance with those expectations.
Eric Henry, a senior quality systems and compliance adviser in the FDA and Life Sciences practice of the law firm King & Spalding, and Christopher Gates, director of product security at Velentium, provide additional must-know information you need to stay compliant. Think design controls, the importance of threat modeling and vulnerability assessment as a component of cybersecurity defense, and how a firm may best interact with FDA investigators and other auditors not familiar with cybersecurity basics.
If you aren’t up on the current state of cybersecurity regulatory requirements and common themes to be found in the regulatory literature, never fear: they touch on it all. You’ll come away empowered to thrive in any inspection scenario involving cybersecurity.
- How cybersecurity activities fit into traditional design controls and safety risk management for medical devices when integrating into quality management systems
- What the FDA is already addressing in inspections from its new draft cybersecurity guidance
- How to address postmarket cybersecurity activities during inspections
- Common themes in the current library of cybersecurity regulations, standards and guidance
- What you must know about new cybersecurity regulations, standards, guidance and/or white papers in progress that will have a significant impact on the medical device industry beyond the FDA’s draft guidance
- Some of the most common cybersecurity deficiencies found during FDA inspections and notified body audits — and how to ensure these are not found in your organization
How well will you defend cybersecurity at your next inspection? Attend this webinar to ensure success.
Meet Your Presenters
Eric Henry is a senior quality systems and compliance adviser in the FDA and Life Sciences practice of the law firm King & Spalding. He has 30 years of global leadership and practitioner experience in a variety of quality, compliance and product development roles, with a specialization in large organizational change and remediation programs, software quality (including cybersecurity), medical device design controls, risk management, audit management and management controls.
Christopher Gates is the director of product security at Velentium. He frequently collaborates with regulatory and standards bodies, including the NTIA, MITRE, Bluetooth SIG, IEEE, the U.S. Department of Commerce and the FDA to present, define and codify tools, techniques and processes that enable the creation of secure medical devices. He promotes the “secure development lifecycle,” the industry-leading approach that eases the burden on developers and ensures high-quality products to save and improve lives.
Who Will Benefit
- Quality assurance leaders and staff
- Regulatory affairs leaders and staff
- R&D leaders and staff
- Software development leaders and staff
- Program managers
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March 8, 2023