AI Assurance DirectoryAI assurance tools for Medical devices
AI-enabled device software, IEC 62304 software lifecycle and EU MDR plus AI Act interplay. Industry tags come from the cited public pages, not from our judgment.
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Aligned Elements
Medical-device ALM and eQMS for design-control and technical-file work. Homepage names pre-defined IEC 62304 Design Control templates. Regulatory-compliance page names IEC 62304-1:2015 software safety classification. Not an FDA PCCP product.
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Astah System Safety (GSN)
GSN modeling in Astah System Safety. Names GSN Community Standard version 1.0 and OMG SACM (ARM) import/export, plus SysML Requirement-to-Goal sync, STPA/STAMP, Auto-Layout and an in-app Script Editor. Marketing page lists automotive (ISO 26262), aerospace (DO-178B), rail, nuclear and defense.
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BTC TestStack
Testing stack (successor to BTC EmbeddedPlatform / EmbeddedTester) for model-based, hand-written and AI-generated code. TÜV Süd certificate names ISO 26262 (automotive), IEC 61508-3 (industrial) and IEC 62304 (medical). ISO 26262 TCL including ASIL D.
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ComplianceQuest Medical Device QMS
Salesforce-native QMS and PLM for medical device manufacturers. Official SaMD page names FDA Predetermined Change Control Plans (PCCP), IEC 62304 lifecycle requirements, cybersecurity documentation and IMDRF SaMD guidance. Not a model verifier.
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CycloneDX (AI/ML-BOM)
OWASP/Ecma TC54 BOM standard (CycloneDX 1.7, released 21 October 2025) published as ECMA-424 2nd edition (10 December 2025). Homepage names 260+ tools, the defense industrial base, satellite and space systems, and medical-device HBOM/SBOM. The ML-BOM guide names the EU AI Act and NIST AI RMF.
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ENVOLOK
Command-line program that checks a modification against an FDA-authorized Predetermined Change Control Plan before it ships. Official page: DEPLOY, BLOCK or UNKNOWN; offline; no network calls during evaluation. Not a QMS or model verifier.
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Greenlight Guru (SiMD/SaMD)
QMS and product-development software for software-enabled medical devices (SiMD/SaMD). Official page says the solution auto-generates audit-ready records to stay compliant with IEC 62304, linking tests and design changes to the DHF. Not an FDA PCCP authoring product.
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IEC Certification Kit (for ISO 26262 and IEC 61508)
MathWorks kit of TÜV SÜD certificates and qualification work products for ISO 26262 (ASIL A–D), IEC 61508 (SIL 1–4) and IEC 62304. Supported-products table names IEC 61511:2016 for PLC Coder. ISO 26262 guidance covers AI-assisted model editing, review and test generation.
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INTEGRITY RTOS
Separation-kernel RTOS with integrated platforms for automotive, industrial safety, medical devices and avionics. Certifications named: ISO 26262 ASIL D, IEC 61508 SIL 3, FDA Class II and Class III medical device approval, and DO-178B/C DAL A for INTEGRITY-178. Not an AI model verifier.
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Jama Connect for Medical Device & Life Sciences
Requirements, risk and V&V platform for medical device and life-sciences teams. Official frameworks list includes Medical Software Development: IEC 62304, plus FDA 21 CFR 820.30, EU MDR and ISO 14971. Suitably validated by TÜV SÜD for safety-related development. Not an FDA PCCP product.
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LDRA (AI and machine learning capability)
LDRA AI/ML capability page covering test generation, change-impact analysis and AI/ML in safety-critical sectors. The aviation section names EASA guidance for Level 1 and 2 machine-learning applications. Not a neural-network verifier.
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Parasoft C/C++test
Unified C/C++ static analysis, unit testing, MC/DC coverage and requirements traceability. TÜV SÜD–certified C/C++test names automotive (ISO 26262), medical (IEC 62304), industrial (IEC 61508) and aerospace/defense (DO-178C DAL A). Badges also list ISO/PAS 8800.
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Perforce QAC
Static analyzer for C, C++ and Rust (formerly Helix QAC). TÜV SÜD certified for ISO 26262 (automotive) up to ASIL D, IEC 61508 (general industry) up to SIL 4, and IEC 62304 (medical devices) up to Software Safety Class C. Also names a DO-330 pack for DO-178C. Not a neural-network verifier.
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QNX OS for Safety
Safety-certified microkernel RTOS (QOS 8.0) certified by TÜV Rheinland to ISO 26262 ASIL D, IEC 61508 SIL 3, IEC 62304 Class C and ISO/SAE 21434. C/C++ toolchains classified TCL3/T3. FAQ names car, surgical robot, drone, power plant, machinery and control systems. Not an airborne runtime.
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Stages Process Management Software
Process-management software with bidirectional traceability between process models and standard objectives. Official table names ISO 26262, ISO/PAS 8800 and UL 4600 under Automotive; IEC 62304 under Medical devices; IEC 61508 and IEC 61511-1 under Industrial.
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TESSY
Automated unit, module and integration testing of embedded C/C++. Official page: qualified for IEC 61508, IEC 62304, ISO 26262 and EN 50128. Call Pair Coverage is named as an ISO 26262 alternative for integration tests. TÜV SÜD certificate names ISO 26262-8:2018.
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VectorCAST
Embedded unit, integration and coverage test automation for C, C++ and Ada. Used in aerospace, automotive, medical device, industrial and railway programs. Tool validation packages for IEC 61508, ISO 26262 and IEC 62304 include TÜV SÜD certificates. Reqs2x AI tests require engineer review.
Questions
Why are only these tools tagged Medical devices?
Industry tags come from the cited public pages, not from our judgment. If a vendor page does not name this industry, the listing does not get the tag.
Where is the cited industry overview?
The Medical devices overview cites official sources and links frameworks and articles for this industry.