Quality systems, regulatory readiness, design control, and IP protection — embedded from concept to clinical deployment.
First principle
BIQADX builds governance into the architecture — not as an afterthought.
Quality systems, regulatory readiness, design control, and IP protection are embedded from concept to clinical deployment — because clinical trust cannot be bolted on after the product is built.
Stage-gate discipline
Concept → R&D → Prototype → Pilot → Regulatory → Clinical — where advancement is governed by verified evidence, not schedule alone.
Detection principle, target analyte, and platform-fit hypothesis.
Gate · Scientific feasibility reviewInternal benchmarking, signal characterisation, chemistry proof.
Gate · R&D exit evidence reviewPlatform–assay integration, engineering verification, early workflow.
Gate · Prototype verification sign-offDeployment readiness, operating consistency, structured output.
Gate · Pilot readiness gateRegistry documentation, comparator logic, evidence construction.
Gate · Regulatory submission readinessExternal validation, study-design architecture, post-market surveillance.
Gate · Clinical evidence governanceCompliance architecture
ISO 13485-oriented QMS thinking from day one of R&D, so every requirement is traceable to risk, design input, and verification.
Every change to hardware, chemistry, software, cartridge geometry, or workflow triggers structured impact assessment.
Diagnostic outputs remain local, encrypted, auditable, and governed at each workflow state rather than treated as a cloud afterthought.
Regulatory readiness is built into the platform before any market engagement, from technical files to comparator logic.
Stage transitions are earned through layered evidence, with controls that keep prototype claims separate from clinical validation.
Platform innovations are protected across instrument architecture, microfluidics, materials, inference logic, and software workflows.
Compliance frameworks
BIQADX is at research, prototype, and engineering-development stages. Framework alignment described here reflects design intent and governance architecture — it does not constitute certification, regulatory clearance, or clinical validation, none of which have been obtained.
Data architecture
Diagnostic data and patient results are governed at the platform level. Every output is structured, encrypted, traceable, and locally controlled.
Trust is not assumed. It is enforced at every interface, every output, every audit event.
Intellectual property
BIQADX pursues structured IP governance across every layer of the platform — from microfluidic geometries and assay chemistries to AI inference models, software workflows, and sustainable materials.
Governance is not the last step. It is the first principle.