Quick, no-signup tools that mirror how the FDA actually reviews cyber devices. Use them to scope work, find gaps, and pressure-test your submission story before a reviewer does.
Figure out which rules apply, which pathway you're on, and what the FDA will actually ask for.
Pick your device type and use case. Get the chain that actually applies - FD&C Act §524B, ANSI/AAMI SW96:2023, IEC 81001-5-1, IEC 62304, ISO 14971 - with an applicability verdict, deliverables, and the harm severity floor for that profile.
Open toolFor machine learning-enabled devices: every CR515:2025 topic area mapped to the GMLP control, PCCP clause, AIBOM entry, and Section 524B obligation it feeds. Filter by area and export as PDF or CSV.
Open toolDoes your device meet the FD&C Act §524B 'cyber device' definition? Six questions tell you whether SBOM, coordinated vulnerability disclosure, postmarket monitoring/patching, and the reasonable-assurance argument are statutorily mandatory.
Open toolClassify your product as Software as a Medical Device or Software in a Medical Device, then map it to EU MDR Rule 11 risk class and the cyber evidence each path requires.
Open toolFive questions → 510(k), De Novo, or PMA recommendation, with the cybersecurity evidence delta for each pathway under the FDA's Feb 3, 2026 final premarket guidance.
Open toolSeven-question score against the FDA's Feb 3, 2026 final premarket cybersecurity guidance with a domain-by-domain gap list and the fastest next move.
Open toolScore your Secure Product Development Framework across governance, design, V&V, postmarket, and supply chain - mapped to the Feb 3, 2026 final premarket guidance and IEC 81001-5-1.
Open toolBuild, diff, and defend the software bill of materials and the components it points to.
Score your software bill of materials + supply-chain program against current FDA premarket and postmarket expectations: format, depth, VEX, monitoring, SLSA build provenance, Sigstore signing, AI-generated code tracking, dependency-confusion defenses.
Open toolPaste two SBOMs (SPDX or CycloneDX). See added / removed / version-bumped components, heuristic KEV-name flags, and a CycloneDX VEX stub ready to publish.
Open toolScore one third-party component on maintenance, provenance, OSSF posture, CVEs, license, origin, AI training-data provenance, and medical-device fit. Get a go / caution / no-go verdict.
Open toolFor devices stuck on Windows 10 IoT, RHEL 7, or unsupported chipsets - generates an FDA-style compensating-controls memo and TPLC verdict.
Open toolMap attack surface, draft your STRIDE register, and scope the pen test before a reviewer scopes it for you.
Rev H / Rev P security and patient-safety matrices using CVSS v4.0 factors and manufacturer evidence. Separate ratings, with manufacturer-owned risk acceptance.
Open toolPick from 17 wireless and physical interfaces - Wi-Fi, Cellular, BLE, BR/EDR, NFC, RFID, USB-OTG, JTAG, CAN, vendor cloud API, companion app, clinician portal, OTA - and get per-interface threats, pen-test scoping, and required premarket evidence.
Open toolPick your interfaces and assets; get a structured STRIDE threat list to drop into AAMI TIR57 / SW96 documentation as the starting point for a formal threat model.
Open toolArchitecture and interface inputs → recommended penetration test scope and rough effort range.
Open toolStand up the monitoring, patch, CVD, and FDA-reporting cadence the guidance expects after launch.
Official CVSS v4.0 score and vector plus a High, Medium or Low exploitability rating for your SW96 risk file.
Open toolRisk class + connectivity + PHI sensitivity → monitoring, patch, pen test, and FDA-reporting SLAs that match reviewer expectations.
Open toolSix questions on reachability, harm, KEV/EPSS signal, access, mitigations, and monitoring → FDA-aligned verdict with next steps and 21 CFR 806 timeline.
Open toolProduce a Section 524B-aligned Coordinated Vulnerability Disclosure policy ready to publish. ISO 29147 structure with your SLAs and contact details baked in.
Open toolScore your patch / OTA update mechanism across signing, transport, deployment safety, and lifecycle. Get critical / high / medium gaps with concrete remediation.
Open toolPull the right artifacts together, draft change-control plans, and respond to deficiency letters.
Sixteen artifacts FDA reviewers look for in the eSTAR cybersecurity sections. Check what you have; we show what's missing and where it goes.
Open toolDraft a Manufacturer Disclosure Statement for Medical Device Security using the 23 sections of ANSI/NEMA HN 1-2019. Markdown export for product security and regulatory review.
Open toolDraft a Predetermined Change Control Plan for your AI/ML-enabled device - a structured 8-section SDS-PCCP outlining modifications, methods, and impact assessment.
Open toolPaste an FDA cybersecurity AI request or hold letter. We pattern-match each ask to a category and outline a structured response with required evidence.
Open toolPick the SIR issue type - auth, crypto, CVE, or SBOM/signing - and get the section-by-section template blocks and example verbiage aligned to the Feb 3, 2026 guidance.
Open toolOne-page printable reference mapping Letter to File, SIR, and Special 510(k) decisions to the cybersecurity factors FDA expects: threat model, SBOM, crypto, auth, verification.
Open toolQuantify what a delay actually costs and make the budget conversation easy.
