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Compliant by DesignTM

The Standard for High-Stakes Compliance Infrastructure

Compliance embedded from design to certification—not retrofitted at the end. Unlock global markets faster, at lower cost, with full audit readiness from day one.

Tracking 10 regimes
EU AI Act·FDA & NIST AI RMF·UK MHRA & AI Framework·NMPA & CAC AI Measures·ANVISA & PL 2338·Health Canada & AIDA·TGA & AI Safety Standard·PMDA & METI AI Guidelines·MFDS & AI Basic Act·ISO/IEC International Baseline·
dataset 2026-06

One continuous thread, from design to certification

01 / Design

Model the system

Your architecture, requirements, and risks enter Complear OS as a living model — not documents. Every component is born traceable.

02 / Embed

Compliance attaches to every component

Standards clauses bind directly to requirements, code, and tests. Evidence is captured continuously as you build — never reconstructed after the fact.

03 / Certify

Evidence seals into an audit-ready artifact

At any moment, the full trace compiles into a cryptographically sealed, regulator-ready submission. Certification becomes a build step, not a year-long project.

complear-os · audit trail

> system model imported · 14 components

> hazard analysis seeded · ISO 14971 §5

> req REQ-114 linked → ISO 14971 §7.1 ✓

> evidence captured · test_run #4821 ✓

> trace complete · design ↔ risk ↔ test ✓

> conformity matrix · 100% coverage ✓

> artifact sealed · sha256:9f2c…a41b

> audit-ready · EU AI Act technical docs ✓

Proven in Production

Trusted by clients and collaborators across regulated industries. Our technology is validated in production and backed by filed patents.

Organisations on Complear OSWith the solution deployed, in regulated industries
15+
Patents FiledProtecting core AI compliance innovations
4

Clients and collaborators

  • UpHill
  • Neurosalience
  • Altice Labs
  • Heart Genetics
  • Fraunhofer
  • F3M
  • Dermavisions
  • Wisify
  • Cardio-ID
  • inSignals
  • BIQ
  • Glintt
View our partner network

Funded and co-funded by

  • PRR - República Portuguesa - Financiado pela União Europeia NextGenerationEU
  • EIT Health
  • Co-funded by the European Union
  • European Innovation Council - Co-funded by the European Union
  • Portugal 2030 - Cofinanciado pela União Europeia
  • NORTE 2030 - Programa Regional do Norte - Cofinanciado pela União Europeia
  • COMPETE 2030 - Cofinanciado pela União Europeia

Trust as a Strategic Advantage

Global certification is at a breaking point. Legacy frameworks—built for static hardware—can't handle AI that learns, adapts, and evolves. The result: innovative firms trapped in archaic paperwork and manual audits that were never designed for autonomous systems.

Complear OS ends the deadlock.

Our AI-native infrastructure replaces document silos with real-time verification, embedding compliance directly into your development lifecycle. Regulatory complexity becomes a growth accelerator, not a barrier.

Explore our infrastructure

Speed to Market

  • 12–18months faster time-to-market
  • +50%documentation speed
  • +80%reduction in compliance maintenance costs

Estimates, not audited results.

Aligned with the Global Standards

Our architecture is built by key contributors to the EU AI Act, ISO/IEC committees, and CENELEC working groups. We do not just guess the future of regulation—we help define it.

  • ISO
  • IEC
  • CENELEC
  • EUROCAE

Sovereign Jurisdictions

Harmonizing compliance architectures across the world's major regulatory regimes.

  • North America
  • EU
  • UK
  • Brasil
  • Australia
  • New Zealand

Which regulations govern your product?

Describe your product in one sentence. Our regime matrix maps the standards and regulations that will apply — resolved at the edge for your jurisdiction.

About Complear

We are building the regulatory infrastructure that powers the next era of the physical economy. Our team combines deep domain expertise with AI engineering to create systems that the world's most demanding industries can trust.

From medical devices that save lives to autonomous systems that shape our future, Complear provides the verification layer that turns innovation into market access.

Learn more about us
  • Infrastructure Company

    We build foundational technology that other companies build upon.

  • Forward-Deployed

    Our engineers embed directly with your R&D teams.

  • Mission-Critical Focus

    We only work with industries where failure is not an option. Medical devices, aircraft systems, autonomous vehicles, and defence platforms.

Tell Us What You Need to Certify

Speak with our Solution Architects to understand how Complear OS can accelerate your path to market while ensuring regulatory certainty.