Medical Device Cybersecurity: Latest Regulatory Developments – Webinar Recording/Transcript
In light of the recent increase in cybersecurity breaches reported in the news, it is essential — now more than ever — to be well-versed in cybersecurity defense of your company’s medical devices. To fully prepare for the regulatory scrutiny of cybersecurity during an inspection of your medical device facility, don’t miss this presentation, led by Eric Henry, an expert with more than 33 years of experience in the life sciences industry.
Henry explains why companies should focus on cybersecurity during facility inspections and device submissions, how the defense of cybersecurity relates to design control, and how risk management relates to cybersecurity threat modeling and vulnerability assessment during inspections.
Presentation learnings include:
- Understand the differences and similarities in global cybersecurity regulatory requirements
- Gain tips for defending cybersecurity during FDA inspections
- Identify and discuss common cybersecurity issues called out during inspections and submission reviews
Don’t miss this opportunity to gain clear insight into how cybersecurity fits into your company’s quality control system and how to best defend your medical devices.
Meet Your Presenter
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.
Who Will Benefit
- Software engineering
- Quality assurance/engineering
- Regulatory affairs
- Functional and business leadership
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Nov. 30, 2023