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ComplyIndex

EU AI Act practitioners for healthcare and medtech

Practitioners
17
Verified
7
Last verified
Countries served
46

Every practitioner below lists healthcare and medtech as a focus industry. Sector context matters: it shapes which use cases are high-risk, what documentation buyers will demand, and what a realistic budget looks like.

Compare practitioners (17 listings)

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Verified July 2026Consultancy

Fogline Systems Assurance

Remote ISO 42001 and EU AI Act conformity programmes for fintech and medtech companies selling on both sides of the Atlantic.

Frameworks
ISO 42001 · EU AI Act · NIST AI RMF +1
Serves
Global
Gap analysis
$15k–$50k
Retainer
$15k–$30k / month
Firm size
11–50 people
HQ
San Francisco, United States
ISO/IEC 42001 Lead ImplementerIAPP AIGP
Verified August 2026Fractional AI governance officer

Jonction Governance Office

Fractional AI governance and privacy officer in Geneva for medtech and digital health firms exposed to EU and US rules.

Frameworks
ISO 42001 · EU AI Act · NIST AI RMF
Serves
Switzerland, EU, US
Gap analysis
Undisclosed
Retainer
$15k–$30k / month
Firm size
Solo practitioner
HQ
Geneva, Switzerland
IAPP AIGPIAPP CIPP
Verified August 2026Consultancy

Kastrup Conformity Lab

Remote EU AI Act conformity preparation and bias testing for Danish health and education technology companies.

Frameworks
EU AI Act · ISO 42001
Serves
Denmark, EU
Gap analysis
$5k–$15k
Retainer
Under $5k / month
Firm size
2–10 people
HQ
Copenhagen, Denmark
IAPP AIGP
Verified August 2026Consultancy

Saltmarsh Conformity

EU AI Act gap analysis and high-risk conformity documentation for Irish fintech and digital health companies.

Frameworks
EU AI Act · ISO 42001 · GDPR
Serves
Ireland, EU, United Kingdom +1
Gap analysis
$5k–$15k
Retainer
Undisclosed
Firm size
2–10 people
HQ
Dublin, Ireland
IAPP AIGPIAPP CIPP
Verified August 2026Fractional AI governance officer

Beacon Row Governance

Fractional AI governance lead for growth-stage medtech and clinical software companies, six-month minimum retainers.

Frameworks
ISO 42001 · NIST AI RMF · EU AI Act +1
Serves
US, EU
Gap analysis
Undisclosed
Retainer
$15k–$30k / month
Firm size
Solo practitioner
HQ
Boston, United States
IAPP AIGP
Verified June 2026Consultancy

Oudegracht Conformity

EU AI Act and ISO 42001 programmes for medical device and digital health companies that already run an MDR quality system.

Frameworks
EU AI Act · ISO 42001
Serves
EU
Gap analysis
$15k–$50k
Retainer
Undisclosed
Firm size
2–10 people
HQ
Utrecht, Netherlands
IAPP AIGP
Verified July 2026Fractional AI governance officer

Quillon Governance Office

Part-time AI governance lead for medtech and digital health companies that need an owner for ISO 42001 and EU AI Act work.

Frameworks
EU AI Act · ISO 42001 · NIST AI RMF
Serves
United Kingdom, EU
Gap analysis
Undisclosed
Retainer
$5k–$15k / month
Firm size
Solo practitioner
HQ
Bristol, United Kingdom
IAPP AIGPIAPP CIPM
Listed · unverifiedConsultancy

Estuaire AI Practice

Low-cost EU AI Act readiness checks and bias audits for health software and small companies, delivered remotely from Nantes.

Frameworks
EU AI Act · NIST AI RMF
Serves
France, EU
Gap analysis
Under $5k
Retainer
Undisclosed
Firm size
2–10 people
HQ
Nantes, France
IAPP AIGP
Listed · unverifiedConsultancy

Sternberg Consulting

Solo ISO consultant in Saxony building ISO 42001 AI management systems for German SMEs, remote-first, with openly published price ranges.

Frameworks
ISO 42001 · EU AI Act · ISO 27001
Serves
Germany
Gap analysis
Undisclosed
Retainer
Under $5k / month
Firm size
Solo practitioner
HQ
Netzschkau, Germany
CQI/IRCA ISO 9001 Lead Auditor course PR328 (ULN 606399)CQI/IRCA ISO 14001 Lead Auditor course PR315 (ULN 606399)CQI/IRCA ISO 45001 Lead Auditor course PR357 (ULN 606399)
Listed · unverifiedConsultancy

DPO Consulting

Paris privacy consultancy extending outsourced-DPO work into EU AI Act maturity assessments, governance design and training.

Frameworks
EU AI Act · GDPR
Serves
Global
Gap analysis
Undisclosed
Retainer
Undisclosed
Firm size
11–50 people
HQ
Paris, France
Digital Ethics Officer
Listed · unverifiedLaw firm

Studio Legale Ostiense

Small Rome law practice advising health providers, medtech vendors and insurers on AI Act and GDPR, retainer only.

Frameworks
EU AI Act · GDPR
Serves
Italy, EU
Gap analysis
Undisclosed
Retainer
Undisclosed
Firm size
2–10 people
HQ
Rome, Italy
Bar admission
Listed · unverifiedConsultancy

CBIZ Pivot Point Security

ISO 42001 and EU AI Act consulting for small and mid-sized US businesses from a security practice founded in 2001, now part of CBIZ.

Frameworks
ISO 42001 · EU AI Act · NIST AI RMF +3
Serves
US, EU
Gap analysis
Undisclosed
Retainer
Undisclosed
Firm size
11–50 people
HQ
Melville, United States
ISO 27001 Certified Lead AuditorCISA
Listed · unverifiedLaw firm

DLA Piper

Global law firm advising AI providers, deployers and employers on EU AI Act, NYC LL144 and privacy compliance, with AI legal red-teaming.

Frameworks
EU AI Act · NYC LL144 · GDPR
Serves
Global
Gap analysis
Undisclosed
Retainer
Undisclosed
Firm size
250+ people
HQ
New York, United States
Bar admission
Listed · unverifiedFractional AI governance officer

The DPO Centre

Outsourced DPO firm offering fractional AI Officers and EU AI Act readiness work alongside its GDPR practice.

Frameworks
EU AI Act · GDPR
Serves
United Kingdom, EU, Canada
Gap analysis
Undisclosed
Retainer
Undisclosed
Firm size
51–250 people
HQ
London, United Kingdom
IAPP AIGPIAPP CIPP
Listed · unverifiedConsultancy

Assessed Intelligence

Fractional Chief Responsible AI Officer (vCRAIO) retainers and AI audit readiness aligned to the EU AI Act, ISO 42001 and NIST AI RMF.

Frameworks
EU AI Act · ISO 42001 · NIST AI RMF +2
Serves
US, United Kingdom, EU
Gap analysis
Undisclosed
Retainer
Undisclosed
Firm size
11–50 people
HQ
Canton, United States
CISSPForHumanity Certified Auditor (GDPR)BSI-certified ISO/IEC 42001 Practitioner+1 more
Listed · unverifiedLaw firm

Mason Hayes & Curran

Dublin business law firm with a dedicated AI practice advising on EU AI Act classification, compliance planning and AI contracting.

Frameworks
EU AI Act · GDPR
Serves
EU, United Kingdom, US
Gap analysis
Undisclosed
Retainer
Undisclosed
Firm size
250+ people
HQ
Dublin, Ireland
Bar admission
Listed · unverifiedCertification body

Schellman

US certification body for ISO 42001 with a dedicated AI practice spanning NIST AI RMF, EU AI Act and AI security assessments.

Frameworks
ISO 42001 · EU AI Act · NIST AI RMF +3
Serves
Global
Gap analysis
Undisclosed
Retainer
Undisclosed
Firm size
250+ people
HQ
Tampa, United States
Accredited certification body×2

All EU AI Act compliance practitioners

Common questions

Is healthcare and medtech AI high-risk under the EU AI Act?

AI that is itself a medical device or a safety component of one is high-risk through the MDR/IVDR route in Annex I, and Annex III adds emergency triage and dispatch systems. Much clinical AI is therefore in scope, and where the device class already requires a notified body, the AI Act assessment runs through that body.

How much does EU AI Act compliance cost for a healthcare and medtech company?

Of the 5 healthcare and medtech practitioners on this page that disclose a gap-analysis band, the most common is $15k–$50k (40% of those disclosing). Sector-specific documentation — bias testing, clinical evidence, model cards for procurement — drives the upper end. Compare disclosed bands and request intros from two or three shortlisted providers.