Does this certify a device as conforming?

No. The workflows produce a cited gap analysis and a STRIDE threat model against MDR/IVDR and the security obligations — decision-support, not a conformity verdict or a notified-body assessment.

Is national health law covered?

The EU regulations (MDR, IVDR, CTR, EHDS) and GDPR are covered at article level. Beyond the EU, US federal health regulation from the FDA (21 CFR) and CMS (42 CFR) is served verbatim, with the FDA final guidances on Premium and above, and dedicated device-regulation text covers Great Britain, Canada, Switzerland, South Korea, Japan, Australia and Colombia. National health statutes are also reachable inside the audited national-law corpora.

Sector · Healthcare

Healthcare & medical devices

Medical-device regulation and health-data privacy, grounded article by article.

Ansvar is a gateway for the AI assistant your team already uses — Claude, Microsoft Copilot, any MCP client. Connect it, and every answer below comes back cited to the provision or marked unresolved.

See full coverage

MDR · IVDRarticle-level + annexes

Art. 9special-category health data

FDA · CMSUS federal health regulation

MDR, IVDR, the Clinical Trials Regulation and the European Health Data Space are served at article level, alongside GDPR Article 9 for special-category health data and the horizontal cyber regimes. Beyond the EU, US federal health regulation from the FDA and CMS comes verbatim from the eCFR, and device regulation for seven more jurisdictions — Great Britain, Canada, Switzerland, South Korea, Japan, Australia and Colombia — is attributed per provision. The device software, safety-risk and security standards are a clause map on top. Ask the provision; then run the DPIA, gap analysis or device threat model that turns it into evidence.

what we cover

The law and standards we ground on

Regulation

Medical Device Regulation (Reg (EU) 2017/745)

article-level, incl. annexes

Regulation

In Vitro Diagnostic Regulation (Reg (EU) 2017/746)

Regulation

Clinical Trials Regulation (Reg (EU) 536/2014)

Regulation

European Health Data Space (Reg (EU) 2025/327)

Regulation

GDPR Art. 9 — special-category health data (+ full GDPR)

Regulation

US federal health regulation — FDA (21 CFR) and CMS (42 CFR)

served verbatim from the eCFR

Regulation

National medical-device regulation outside the EU — GB, CA, CH, KR, JP, AU, CO

device-regulation text attributed per provision to the jurisdiction that issued it

Standard

Control mapping: medical-device software, safety and security standards

97 clauses across IEC 62304, IEC 81001-5-1, ANSI/AAMI SW96 and AAMI TIR57, ISO 14971, IEC 60601-1 (incl. clause 14 PEMS), IEC 82304-1 and the surgical- and rehabilitation-robot parts IEC 80601-2-77/-78 — clause map + Ansvar cross-refs, not the standard text

Regulation

Horizontal: NIS2 · EU AI Act (software as a medical device) · CRA

GuidancePremium

MDCG medical-device guidance

GuidancePremium

US FDA guidance documents

48 final guidances on medical-device, drug and biologics regulation, served verbatim

GuidancePremium

Dutch statutory disciplinary-tribunal rulings

48,205 full-text decisions from 2001 onward — the regional healthcare colleges and the Centraal Tuchtcollege alongside the advocatuur, notariaat, accountancy, veterinary and maritime tribunals

what you can do

Workflows that turn it into evidence

Team

DPIA for special-category health data

GDPR Art. 35 + Art. 9, with Germany and Sweden variants

Team

Regulatory gap analysis

against MDR / IVDR / GDPR / NIS2, with a dedicated NIS2 variant

Premium

Medical-device product-security threat model

STRIDE over a device data-flow diagram — not a device-conformity verdict

Premium

LINDDUN privacy threat model

for clinical and patient-data flows

Team

FRIA — EU AI Act Art. 27

for AI-based devices and high-risk software-as-a-medical-device AI

Team

Document review, paragraph-cited

technical documentation, clinical SOPs and QMS documents

assembledPremium

Device software & security standards research as cited answers

the IEC 62304 / 81001-5-1 / ISO 14971 clause map and the FDA guidance layer, every answer cited to its source

STRIDE threat-model workflows run on every plan against a system you describe — 1 run a month on Free, 2 on Solo, 5 on Premium, which also adds the LINDDUN and TARA families, the rendered reports, and case law inside the run. Document-grounded workflows run on Team and Company. Every tier runs the same corpora as cited research inside your own AI client.

Questions buyers ask first

Does this certify a device as conforming?: No. The workflows produce a cited gap analysis and a STRIDE threat model against MDR/IVDR and the security obligations — decision-support, not a conformity verdict or a notified-body assessment.
Is national health law covered?: The EU regulations (MDR, IVDR, CTR, EHDS) and GDPR are covered at article level. Beyond the EU, US federal health regulation from the FDA (21 CFR) and CMS (42 CFR) is served verbatim, with the FDA final guidances on Premium and above, and dedicated device-regulation text covers Great Britain, Canada, Switzerland, South Korea, Japan, Australia and Colombia. National health statutes are also reachable inside the audited national-law corpora.

Run it against your own systems

Connect the AI client you already use and ask your first cited question — Free, Solo, Premium and Team are self-serve.

Setup guide

Building healthcare compliance? It works today — we take on a few design partners per sector to tune it to your team.