Regulatory Ledger
BiQadx operates under a phase-gate development cycle explicitly designed to mirror the world's most aggressive regulatory pathways.
ISO 13485 Standard
Entire R&D documentation pipelines—from initial risk hazard analysis to final design verification protocols—are built in native ISO 13485-compliant formats. This structurally aligns BiQadx with CE-IVDR and FDA 510(k) auditing standards at step zero.
Six Sigma Tolernaces
Diagnostic drift cannot exceed 0.1% CV. Our optical alignments, centrifugal micro-mold gating, and INT8 inference pipelines are designed to output with a DPMO (Defects Per Million Opportunities) approaching statistical zero <3.4.
Cleanroom Class 7
Reagent deposition, lyophilized bead manufacturing, and target cartridge sealing are mapped exclusively to ISO Class 7 (Class 10,000) environments, assuring absolute biosafety and preventing rogue DNA/RNA amplification.
End-to-End Traceability.
BiQadx maintains a centralized, immutable traceability matrix. Every functional requirement (FR) is directly coupled to its risk assessment (FMEA), mechanical design input, and empirical verification test.
If a parameter is altered on the Dr. POCT hardware layer, the QMS network automatically flags all cascading compliance dependencies.
Requirements Hierarchy
User Needs (PRD) → Functional Specs → Component Specs (CAD/PCB) explicitly mapped in 1:1 parity.
Cybersecurity CFR 21
Fully compliant electronic signature auditing, user-level permission gates, and edge telemetry AES-256 validation.
Failure Mode Engineering (FMEA)
Bottom-up component failure risk assessment applied equally to physical hardware paths and AI inference algorithms.