Webinars
FDA 510(k) Cybersecurity Requirements: From Guidance to Submission Success
Event Details
Preparing a 510(k) submission is already complex, and cybersecurity requirements often add another layer of uncertainty.
Many teams understand FDA cybersecurity requirements at a high level, but questions often come up during submission preparation. What documentation should be expected? Where does it fit the submission? What gaps or mistakes could lead to delays, RTA holds, or additional reviewer questions?
To help navigate these challenges, Qualysec Technology is hosting a webinar focusing on the practical side of FDA 510(k) cybersecurity expectations. Join us to understand preparation, structure, and presentation of documentation. Whether you are preparing a first submission or strengthening an existing process, this session is designed to help teams approach cybersecurity readiness with greater clarity and confidence.
What You'll Learn
This webinar will dive into the areas that most matter when putting together cybersecurity-related content for a 510(k) submission.
You will learn:
- How the latest FDA cybersecurity guidance is relevant to 510(k) submissions.
- How cybersecurity documentation maps to submission sections.
- Common mistakes that often result in RTA holds and deficiencies.
- Precision that successful submissions do better.
- How to conduct the reality check to submission readiness.
Who Should Attend
- Professionals in regulatory affairs and quality teams, medical device startups working on their first submission, and teams involved in submission planning, documentation, or product compliance.
Quick Submission Readiness Check
- Check the FDA cybersecurity requirements and cyber device criteria to determine whether they are device specific.
- Ensure the depth of cybersecurity, SBOM, and vulnerability assessment evidence is submission-ready.
- Verify threat models, system architecture, and security controls are documented clearly.
- Validate cybersecurity claims with penetration testing and vulnerability assessment evidence.
