Imprint.

Company

Registered name

WiserFrame OÜ

Commercial registry

Estonian Centre of Registers and Information Systems — e-äriregister

Registry code

17497246

VAT number

Not VAT-registered

Registered office

Narva mnt 5
Kesklinna linnaosa, Tallinn
Harju maakond 10117
Estonia

Represented by

Savva Sicevs — Management Board Member

Public contact

hello@wiserframe.com

Regulatory orientation

WiserFrame is a product-design studio. The frameworks we cite throughout this site — HIPAA, GDPR, ISO 13485, IEC 62366 — describe the regulatory environment our clients operate in, and the patterns we follow when working inside that environment.

WiserFrame is not a certified medical device manufacturer. We do not hold our own ISO 13485 certification or 510(k) clearance, and we do not place medical devices on any market under our own name. We work as the design partner inside our clients' regulated workstreams.

How we use each framework

• HIPAA-aware. We handle US client data the way a Business Associate is expected to. We sign a BAA before any PHI changes hands and we work against synthetic or de-identified data by default.
• GDPR-aware. We apply purpose limitation, data minimisation, and retention discipline by default. We sign a Data Processing Agreement before processing personal data on behalf of EU clients.
• ISO 13485-aware. Our deliverables follow the design-control patterns ISO 13485 expects: traceable design decisions, change history aligned to risk, and a clean handover to the client's QMS.
• IEC 62366-aware. We produce the artifacts that feed a usability-engineering file: user research, use-error analysis, formative testing notes, and design rationale tied to identified hazards.

Contracts we sign

• Mutual NDA before any client material is shared (default).
• Data Processing Agreement (DPA) for any GDPR-covered processing.
• Business Associate Agreement (BAA) for any HIPAA-covered processing.
• IP assignment clauses tied to deliverable acceptance, on request.

Subprocessors

• Vercel — hosting and CDN for this site. Cookieless analytics. Privacy policy.
• GitHub — source-control for this site and select project repositories.
• Calendly — intro-call scheduling. Privacy policy.
• Stripe — payment processing for the Diagnostic Working Session. Privacy policy.

Disclaimer

Site content — including the dashboard mockups, the Supervision Queue documentation, and the component library — is illustrative. Nothing on this site is medical advice or a substitute for clinical judgment, and no content here describes a regulated medical device released by WiserFrame.

Questions? Email hello@wiserframe.com — we reply within two working days.