5 Cybersecurity Moves That Keep Your FDA Submission Off Hold

Overview

Cybersecurity documentation is where many device submissions stall. Nick Butt and Acacia Parks walk through the five moves that matter for a review: security architectures that detail your data flows, a threat model covering the architecture ins and outs, an SBOM that holds up under scrutiny, pen testing scoped for submission rather than internal assurance, and postmarket monitoring documentation.

What we will discuss

• Postmarket monitoring documentation
• Security architectures that detail your data flows
• A threat model covering the architecture ins and outs
• An SBOM that holds up under scrutiny
• Pen testing scoped for submission rather than internal assurance

Speakers

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