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.
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)
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.