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    Benefits of an FDA 510k Gap Analysis

    On-Demand Webinar

    Join our expert-led webinar to gain critical insights into integrating cybersecurity into your FDA 510(k) submissions. As medical devices become increasingly interconnected, ensuring robust cybersecurity measures is not just advisable but essential. This session will provide an in-depth look at how to perform a gap analysis specifically tailored to the cybersecurity components of the FDA 510(k) process.

    Attendees will learn about:

    • Key Cybersecurity Concerns: Understand the specific cybersecurity threats and challenges that pertain to medical devices and how these impact FDA compliance.
    • Regulatory Requirements: Explore the FDA’s current cybersecurity guidelines and expectations for 510(k) submissions, including essential documentation and evidence of risk management.
    • Gap Analysis Framework: Discover a structured approach to identify and address gaps in your cybersecurity practices to support a successful 510(k) submission.
    • Case Studies & Best Practices: Learn from real-world examples and expert recommendations to enhance your device’s security measures and compliance posture.
    This webinar is designed for regulatory affairs professionals, quality assurance teams, and anyone involved in the development and submission of medical devices to the FDA. Equip yourself with the knowledge and tools necessary to fortify your device against cyber threats and streamline your regulatory approval process!

    Length of webinar: 60 mins

    Webinar presenter

    Sean McMahon
    Sean McMahon Round HeadshotSean McMahon is an IT Professional with 30 years of experience helping customers with the digital transformation to the modern workplace. He began his career in 1994 helping organizations with Y2K compliance challenges. He helps solve business challenges with technology solutions and services. He believes the success of modern businesses is dependent on connectivity, ease of access to information, the speed of response, network of collaboration and the ability to make decisions in real-time. To remain competitive and desirable, organizations need to transform the employee work experience by promoting efficiency, innovation and growth as well as breaking down existing communication barriers. The key to success lies in an effective implementation of a digital transformation strategy capable of driving true organizational and cultural change and delivering business value. Sean has dedicated the past 12 years to helping companies with Cybersecurity challenges and initiatives.


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