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Unpacking FDA Guidance: Quality System Considerations and Content of Premarket Submissions
FDA Cybersecurity Testing Requirements - Interview with Red Sentry
FDA Finally Released the 2023 Cybersecurity Final Guidance Document
Unpacking the FDA's New Proposed Rule for Laboratory Developed Tests
How to Prepare a Medical Device 510k Submission for FDA | Rob Packard | Joe Hage
How to Prepare a Medical Device 510k Submission for FDA | Rob Packard | Joe Hage | Updated
154 - How FDA Evaluates Off The Shelf Software
What the FDA’s Proposed Rule to Regulate Lab-Developed Tests Means for Hospitals and Health Systems
Navigating FDA’s New Cyber Device Paradigm - Cybersecurity & Compliance, Industry Best Practices
Webinar: FDA Cybersecurity - From Guidance to Legal Requirements (Aug. 2023)
Integrated Assessment of Marketing Applications and Integrated Review Documentation Workshop
Updates & Trends from FDA; Including Recent ISO 10993 News