Insights

Field notes from the MedTech security trenches.

Deep dives on FDA expectations, threat modeling, penetration testing, SDLC, and the standards your team is being asked to meet.

FDA· May 17, 2026

FDA Deficiency Letter vs RTA vs Hold

FDA Deficiency Letter, RTA, and Hold Letter explained side-by-side. What each one means, the clock impact, and how to respond without losing months.

#Primer

Read article

FDA· May 10, 2026

eSTAR 510(k) Cybersecurity Documentation

Every cybersecurity artifact the FDA expects in an eSTAR 510(k): Section Q mapping, SBOM, threat model, SPDF evidence, and traceability matrix.

#FDA#eSTAR#510(k)

Read article

Threat Modeling· May 8, 2026

Brainjacking: The Real Cyber-Physical Threat to NeuroTech

Brainjacking is unauthorized control of an implanted neurostimulator. We unpack attack vectors, clinical consequences, and what FDA reviewers expect.

#Threat Modeling

Read article

FDA· Apr 10, 2026

FDA Postmarket Cybersecurity for Cleared

FDA postmarket cybersecurity guidance for cleared medical devices: SBOM monitoring, validated patches, CVD, and 21 CFR Part 806 reporting under Section 524B.

#FDA#Postmarket

Read article

Pen Testing· Apr 10, 2026

Medical Device Pen Testing Providers

When penetration test reports are vague, incomplete, or written to enterprise IT standards rather than medical device requirements, FDA reviewers issue.

#Pen Testing

Read article

FDA· Apr 10, 2026

How to Respond to an FDA Cybersecurity

Receiving an FDA cybersecurity Additional Information Request (AIR) doesn't mean your submission is dead. Aligned with the FDA's Feb 3, 2026 premarket.

#FDA#AI

Read article

FDA· Apr 10, 2026

ISO 27001 & SOC 2 vs FDA Medical Device

Why ISO 27001 and SOC 2 don't satisfy FDA medical device cybersecurity: the gaps in Section 524B evidence and what reviewers require instead.

#FDA#Standards

Read article

FDA· Apr 9, 2026

FDA Cybersecurity Deficiencies Triggers

Understanding what causes the FDA to issue a cybersecurity deficiency for medical devices starts with one uncomfortable truth: most deficiencies have.

#FDA

Read article

FDA· Apr 9, 2026

510(k) Cybersecurity Requirements Every Maker Must Meet

FDA 510(k) cybersecurity requirements - threat model, SBOM, testing, postmarket plan - scaled across 510(k), De Novo, and PMA pathways under Section 524B.

#FDA#510(k)

Read article

FDA· Apr 9, 2026

FDA Cybersecurity Documentation

FDA cybersecurity documentation requirements (2026): SPDF artifacts, Section 524B evidence, SBOM, threat model, testing, and labeling reviewers expect.

#FDA#Documentation#SPDF

Read article

FDA· Apr 9, 2026

Medical Device Cybersecurity Risk Analysis

Performing a thorough cybersecurity risk analysis for a medical device isn't optional once your product qualifies under Section 524B of the FD&C Act.

#FDA#Risk

Read article

FDA· Apr 9, 2026

Medical Device SBOM: FDA Requirements Guide (2026)

The four SBOM elements FDA reviewers verify at RTA screening under Section 524B: format (CycloneDX/SPDX), identifiers (PURL/CPE), vuln disposition, update process.

#FDA#Premarket#SBOM

Read article

Ready when you are

Get FDA cleared without the cybersecurity headaches.

30-minute strategy session. No cost, no commitment - just answers from people who've shipped 250+ FDA submissions.