Every article in our archive tagged Postmarket.
Showing 12 of 17 articles tagged Postmarket · Page 1 of 2
The FDA PCCP guidance isn't AI-only. Use a predetermined change control plan for cybersecurity patches, firmware updates, and SBOM component swaps.
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What happens if you fail an FDA cybersecurity inspection: the 483-to-consent-decree enforcement ladder and the commercial fallout for device makers.
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How to document update cadence for an FDA §524B submission: the regular cycle and the out-of-cycle expedited path reviewers expect under §524B(b)(2)(B).
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FDA Section 524B applies to any new premarket submission for a cyber device, including legacy platforms.
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What medical device cybersecurity actually costs in 2026: four cost drivers, fixed-fee vs hourly pricing, and premarket vs postmarket budget lines.
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The threat intelligence sources medical device manufacturers should monitor to satisfy FDA Section 524B postmarket obligations: H-ISAC, CISA KEV, ICS.
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A subsection-by-subsection walkthrough of FDA Section 524B for cyber medical devices: what §524B(a), (b)(1), (b)(2), (b)(3), (b)(4), and (c) require.
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How to run CAPA for medical device cybersecurity findings: when a vulnerability or FDA deficiency triggers a CAPA, and what evidence closes it out.
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How Health Canada regulates medical device cybersecurity in 2026: pre-market license expectations, MDEL obligations, and how to reuse an FDA Section 524B.
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What the FDA's Feb 3, 2026 final premarket cybersecurity guidance expects from a medical device incident response plan, who owns it, and the documents.
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How to design, isolate, and defend the update channel for connected medical devices - signed manifests, dual-bank A/B, rollback protection, HSM-backed.
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EOS vs EOL vs Level of Support in your medical device SBOM: what Section 524B requires, how to express it in CycloneDX and SPDX, and how to defend it.
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