Every article in our archive tagged Postmarket.
Showing 12 of 16 articles tagged Postmarket · Page 1 of 2
What happens if you fail an FDA cybersecurity inspection: the 483-to-consent-decree enforcement ladder and the commercial fallout for device makers.
Read article
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).
Read article
FDA Section 524B applies to any new premarket submission for a cyber device, including legacy platforms. What attaches, what postmarket rules cover the rest.
Read article
What medical device cybersecurity actually costs in 2026 - the four cost drivers, fixed-fee vs hourly pricing, premarket vs postmarket budget lines, and the cost of delay.
Read article
The threat intelligence sources medical device manufacturers should monitor to satisfy FDA Section 524B postmarket obligations: H-ISAC, CISA KEV, ICS advisories, NVD, MITRE ATT&CK for ICS, and vendor PSIRTs.
Read article
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, what artifacts satisfy each, and the deficiency patterns reviewers flag most.
Read article
How to run CAPA for medical device cybersecurity findings: when a vulnerability or FDA deficiency triggers a CAPA, what evidence closes it, and how the QMSR loop ties to §524B postmarket obligations.
Read article
How Health Canada regulates medical device cybersecurity in 2026: pre-market license expectations, MDEL obligations, and how to reuse an FDA Section 524B package.
Read article
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 reviewers look for.
Read article
How to design, isolate, and defend the update channel for connected medical devices - signed manifests, dual-bank A/B, rollback protection, HSM-backed signing, TUF/Uptane, and what the FDA expects in the submission.
Read article
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 in.
Read article
FDA clearance is the beginning of your cybersecurity obligations, not the finish line.
Read article30-minute strategy session. No cost, no commitment - just answers from people who've shipped 250+ FDA submissions.
