Section 524B made medical device cybersecurity a legal requirement, not a guideline.
Semiconductor manufacturers face dual compliance obligations under CMMC 2.0 and the CHIPS Act and a standard pen test satisfies neither fully.
Completing a pen test isn't enough for CMMC.
Annual penetration testing produces documentation, not security.
Don't wait for an auditor to tell you what you missed.
Learn how to safely scope IT-OT penetration testing engagements.
Annual pen testing fits a budget cycle but it doesn't reflect how fast manufacturing environments actually change.
21 CFR Part 11 and cGMP don't mention penetration testing but the controls they require depend on it.
R&D and GxP regulated environments have different risk profiles, compliance requirements, and testing constraints.
