MEOK for Healthtech

Healthtech AI compliance — Article 50 + SaMD + HIPAA + FDA AI/ML

days to EU AI Act Article 50 (2 Aug 2026 cliff)

Symptom checkers, telemedicine triage, drug discovery, clinical trial AI — all in scope. MEOK signs a regulator-grade attestation across EU MDR + FDA + HIPAA + Article 50 in days, not months.

Top obligations (healthtech)

EU AI Act Annex III (5) — medical device AI = high-risk

EU MDR — Medical Device Regulation

FDA AI/ML SaMD — Software as a Medical Device guidance

HIPAA — PHI handling, BAA generator

3 case studies in this vertical

UK Telemedicine

Symptom checker classified Annex III (5) + signed Article 50 cert.

Read the case study →

EU MedTech scaleup

EU MDR + FDA AI/ML crosswalk in 2 weeks.

Read the case study →

US Health Insurer

HIPAA + GINA compliance attestation for risk-adjustment AI.

Read the case study →

3 MCP tools for healthtech

eu-ai-act-compliance-mcp

Medical device AI risk classification + 42-pt audit

fda-samd-mcp

SaMD classification + FDA AI/ML documentation

hipaa-compliance-mcp

HIPAA safeguards + PHI handling + BAA generator

Pricing

Free

£0

200 calls/day per MCP. No signed receipts.

All 32 MCPs in the catalogue
Free-tier /sign endpoint
Community support

Start free →

Pro MOST POPULAR

£199/mo

1,000 calls/day per MCP. Ed25519-signed receipts.

All 32 MCPs in the catalogue
Signed Ed25519 attestations
Public verify URL per cert
Priority support
Offline verification tool

Buy Pro →

Enterprise

£1,499/mo

Multi-tenant. Co-branded receipts. On-prem option.

Everything in Pro
Co-branded attestations
Multi-tenant provisioning
On-prem deployment
Dedicated CSM

Buy Enterprise →

48h Assessment

£5,000one-time

Full healthtech audit + remediation backlog + signed cert.

Full governance report
All in-scope frameworks
Remediation backlog with line-item owners
Signed Article 50 attestation

Buy the Healthtech Compliance Pack →

Get from "in scope" to signed Article 50 in 4 days

Same tooling the UK challenger bank used. Same tooling the care home operator used. Same tooling the HR-tech scaleup used.

Buy Pro £199/month → Book 48h Assessment £4950 → Book scoping call →