Healthcare, Medtech & Pharma
Usability that stands up to a regulator, not just a design review.
Why it fits
- Safety-critical interfaces where usability is regulatory (IEC 62366).
- Patient-facing digital health (DiGA, portals, telehealth): flow, accessibility, trust.
- Sensitive health data makes privacy-by-design architectural, not cosmetic.
- Pharma's cautious AI adoption — independent AI-readiness verdicts land well.
When an audit makes sense
A medical-device or digital-therapeutic UI heading into regulatory usability validation
A patient portal / telehealth flow with adherence or drop-off problems
Accessibility exposure on consumer-facing health services (BFSG)
Health-data consent/tracking review
Buying behaviour
- Digital Health Lead, Head of UX/Product
- Regulatory Affairs (gatekeeper), Medical Affairs
- Long, evidence- and compliance-driven cycles
Regulatory context
- MDR and IEC 62366 usability engineering — usability findings can carry regulatory weight.
- DiGA fast-track (DE) with UX, data-protection, and interoperability requirements.
- GDPR special-category (health) data → elevated consent and minimisation duties.
- BFSG / WCAG 2.2 for consumer-facing health services; Switzerland: revFADP + Swissmedic.
How we position
- “Usability that stands up to a regulator, not just a design review.”
- Accessibility and privacy as clinical-grade, not checkbox.
- AI readiness as risk reduction: know before you build.
- Win the regulatory-affairs gatekeeper early.
Recommended services
Qualitative & Heuristic UX Audit
A UX audit systematically evaluates a digital product using established usability heuristics, psychological principles, and real-world usage contexts.
Accessibility Audit (WCAG 2.1+)
An accessibility audit evaluates digital products against WCAG 2.1+ standards across visual, motor, cognitive, and technical dimensions.
Privacy-by-Design Architecture
This module translates legal requirements into concrete design, data, and process decisions.
Consent & Trust Design
This module designs consent flows, cookie banners, and choice dialogs that are clear, fair, and reversible.
Product Vision & Target States
This module develops precise, testable target states: How should the product feel to users in three years?
Relevant case studies
Direct answers
No — we complement formal validation with a rigorous, evidence-based UX diagnosis. We don't replace regulatory validation, but we make it more robust.
By data minimisation: no full-payload logging, no credentials, access only after an NDA. Consent and privacy are treated as architecture.
Yes. We evaluate against WCAG 2.2 / EN 301 549 and map findings to BFSG relevance for consumer-facing health services.
Clarity about your system — with evidence.
A structured, independent audit with a prioritised, buildable path. No credentials, NDA before any confidential access.