Deterministic.
Auditable.
Compliant.
When software decides whether a cardiac signal is clean — or whether audio evidence holds up in federal court — "it usually works" is not an acceptable specification.
ChirpPoint builds deterministic, fully auditable deep technology for medical devices and forensic audio — engineered from first principles for IEC 62304 Class C compliance. Every result is traceable. Every claim is bounded. Every component is documented to the degree the most demanding regulatory frameworks require.
Auditability is not a feature added at the end of a project. It is a structural property — either present in the architecture from the first design decision, or absent in a way no amount of documentation retroactively repairs. ChirpPoint systems are built so that every result can be traced to a defined requirement, every numerical claim can be independently reproduced, and every compliance artifact reflects the actual system — not a description of it.
This page is a controlled disclosure subset. Full system architecture, algorithmic implementation, and internal design are not disclosed here.Verification Standard: IEC 62304 Class C · Internal Protocol CPD-STVI-001
Same Input. Same Output. Every Time.
Every ChirpPoint system produces deterministic output — the same result on every platform, every run, every driver version — without exception.
Stated Error. Independently Verifiable.
Worst-case error is a mathematically established property of the system — not an estimate from a test set. Bounds available through structured disclosure.
Requirement to Binary. No Gaps.
Every design decision, test result, and compliance artifact traces back to a defined requirement. The chain from specification to verified binary is unbroken and independently auditable.
Open the Codebase. Start Immediately.
No black boxes. No undocumented assumptions. No results that depend on training data or model weights. A qualified regulatory reviewer can begin without orientation.
Built for the Courtroom and the OR.
Daubert admissibility requires a known error rate, a testable method, and a forensic record. Every Prism run satisfies all three as a designed-in property — not a post-hoc argument.
Compliance Is the Architecture.
IEC 62304 Class C constraints were imposed before the first line of code. They are not a compliance layer over the system. They are the system.
Two Products. One Standard.
Lattice-Q™
The first commercially available, IEC 62304 Class C-compliant unified GPU solver for medical devices — deterministic execution confirmed on production silicon, April 2026.
A GPU computing system designed from first principles for Class C compliance: real-time hemodynamic simulation and medical signal classification unified under a single verified FP64 numerical core. Compliance documentation is not a deliverable separate from the system — it is produced by the same engineering discipline that produced the system.
Targets NVIDIA A100, H100, and Blackwell B200 (90 TFLOPS FP64). Zero GPL/LGPL contamination in production binary.
- Bit-exact FP64 reproducibility — 10/10 V&V tests passed, drift = 0.0000e+00, April 2026 · not a target, a confirmed measurement
- Physics validation suite distinguishes determinism from correctness — same input → same output is necessary but not sufficient; correct physical results must also be confirmed against reference standards
- IEC 62304 Class C compliance is a structural property of the codebase — traceability, bounded behavior, and anomaly management were imposed as constraints before implementation, not applied after
- Every source file, build artifact, and test log is version-controlled and indexed in the Design History File — the audit trail is continuous, not reconstructed
- Zero GPL/LGPL contamination confirmed — the production binary carries no license obligations that restrict deployment in regulated environments
- Full compliance package — DHF, SBOM, risk management file, tool validation index, threat model — available through structured disclosure to qualified parties under executed NDA
Prism™
The first deterministic, platform-universal engine for precision audio signal analysis — with a mathematically guaranteed, stated error bound.
Prism processes each signal individually, separating audio into clean and artifact components through a proprietary deterministic method that does not rely on a trained model, fixed filter, or predefined transform. The separation is complete: clean + artifact = original, within the stated bound, for every input.
The result is a worst-case reconstruction error that is fixed, stated, and independently verifiable. Fully deterministic across all supported platforms and inputs.
Processing domain selection and parameter derivation are proprietary. Results are deterministic and reproducible across all platforms. Algorithmic detail available through structured disclosure under executed NDA.
- Guaranteed reconstruction — clean + artifact = original, within stated bound, for any input on any supported platform — a mathematical property of the algorithm, not a characterization from a test set
- Processing parameters are derived per signal through a deterministic process — no fixed transform, no trained parameters, no dependence on a prior distribution
- Numerically identical output confirmed across GPU, CPU, and ARM bare metal — the same algorithm, the same results, on all three deployment targets
- Every processing run produces a complete forensic audit log, satisfying Daubert's requirements for a known error rate and independently reproducible methodology
- No training data required — the algorithm operates on any signal without prior exposure; there is no distribution shift risk and no retraining requirement
Beyond the Operating Room.
The same properties that create a structural regulatory position in Class C medical software are direct requirements in several non-medical industries. These are not adjacent opportunities. They are the same problem in a different regulatory language.
Process Qualification & Simulation
- Process qualification requires deterministic, node-identical results — the same requirement that drives the medical compliance story
- Bit-exact numerical reproducibility across compute nodes is a qualification prerequisite under SEMI standards
- Existing V&V infrastructure, SBOM, and build documentation transfer directly to semiconductor qualification workflows
Transport Simulation & Electrochemical Analysis
- Long-duration transport simulations require precision guarantees that prevent cumulative numerical error from invalidating results
- National laboratory programs actively fund GPU-accelerated simulation tools at this precision level
- DOE SBIR pathways are open with current validation posture and documentation
Aerodynamic & Thermal Simulation
- Deterministic GPU simulation applicable to UAV aerodynamics, cooling flow, and avionics thermal management
- Bit-exact reproducibility is a direct DO-178C parallel — documentation demands are structurally identical
- Existing compliance infrastructure and documentation posture map directly to DoD SBIR technical proposal requirements
Anomaly Detection & Process Monitoring
- GPU-accelerated classification of high-dimensional sensor data — vibration, acoustic, thermal, spectroscopic
- Bit-exact reproducibility enables ISO 9001 and TS 16949 qualification of the classification system itself
- A non-deterministic classifier cannot be validated under either standard — structural barrier for alternatives
Process Analytical Technology & Bioreactor Simulation
- Pharmaceutical manufacturing application — no FDA 510(k) required
- Existing IEC 62304 documentation maps directly to FDA PAT validation under 21 CFR Part 211
- The compliance infrastructure already built is a technical differentiator, not overhead
Real-Time Digital Twin Components
- Simulation and classification operating in concert, updated in real time from live sensor streams
- Digital twin validation requires identical results on engineering workstation and plant-floor system
- Applicable to HVAC, cooling systems, water treatment, and chemical process environments
The IEC 62304 Class C documentation suite maps structurally to the verification and qualification requirements of semiconductor (SEMI), aerospace (DO-178C), nuclear (10 CFR 50 Annex B), and pharmaceutical (21 CFR Part 211) regulation. These frameworks share the same underlying demand: deterministic behavior, stated bounds, full traceability, and independently reproducible results. ChirpPoint systems satisfy that demand by construction.
For Engineers & Regulatory Teams.
Architecture and verified results presented at a high level. Core algorithmic implementation, internal design, and numerical bounds are not present in this document.
IEEE-754 precision compliance is enforced at the source level and independently verified against the compiled binary output. Source-level compliance and binary-level compliance are distinct claims — both are audited, and both are confirmed. The specific enforcement mechanisms and audit methodology are not disclosed in this document.
PRECISION COMPLIANCE: CONFIRMED
APPROXIMATION ARTIFACTS: NONE DETECTED
// Audit methodology, compiler configuration, and enforcement mechanisms
// withheld — available through structured disclosure
The documentation set listed below exists and is maintained in a review-ready state. Each item is a confirmed deliverable. Access restricted to qualified parties through formal evaluation processes.
Ten verification tests were run on physical NVIDIA GPU hardware under documented conditions (CPD-ENG-006). All tests passed. Numerical drift across all tests: exactly zero.
FDA 510(k) clearance requires demonstrating substantial equivalence to a predicate device — including a comparable, stated error profile. ChirpPoint systems provide a bounded, stated worst-case error as a structural property. Alternative approaches based on learned inference cannot make the same predicate comparison.
Compliance as Architecture.
Bounded Error. Stated. Verifiable.
IEC 62304 Class C requires that software behavior in patient-safety-critical paths be characterized with a stated, bounded error profile. A system that cannot provide this cannot satisfy the standard — regardless of how well it performs on a test set. ChirpPoint systems provide a defined worst-case error bound as a structural property of the algorithm, not a measurement from a sample.
Precision Verified at the Binary Level.
IEEE-754 compliance is enforced at the source level and independently verified against the compiled binary output. Source-level compliance and binary-level compliance are distinct claims — both are audited, and both are confirmed. The specific enforcement mechanisms and audit methodology are not disclosed in this document.
Documentation Is Not Retroactive.
Design History Files, risk management files, SBOMs, and verification indices are produced in parallel with the code, version-controlled alongside it, and reflect the system as it actually exists. Documentation written after the fact is a description of a system. Documentation written concurrently is evidence of one.
FDA 510(k) Requires a Stated Error Rate.
Substantial equivalence to a predicate device requires a comparable, stated error profile. A system characterized only by test-set performance cannot make that comparison — the bound is distribution-dependent and not transferable. ChirpPoint systems provide a worst-case error bound that holds for any input, making the predicate comparison possible by construction.
Platform-Identical Results Across All Targets.
Lattice-Q targets the NVIDIA B200, H100, and A100. Prism targets GPU, CPU, and ARM bare metal through a single API. In both cases, identical numerical output across all deployment targets is a confirmed property — not a design goal — verified against physical hardware.
Audit Depth as a Measurable Property.
Audit depth — the degree to which an independent evaluator can trace system behavior from requirement to output — is either present at every layer or absent at some. ChirpPoint systems are designed so that the audit chain is unbroken: from the numerical core through the build system through the compliance documentation to the verified binary.
Engineering Discipline as Institutional Standard.
The standard is not software that passes tests.
The standard is software whose behavior is fully characterized before a single test is run.
IEC 62304 Class C is not primarily a documentation standard. It is an engineering standard that happens to require documentation as evidence. The distinction matters: you cannot produce the documentation correctly unless you have built the system correctly. ChirpPoint was designed in that order.
On April 8, 2026, the Lattice-Q engine completed its REV 2 validation — 10/10 V&V tests at exactly zero numerical drift, plus a physics validation suite confirming correct physical results against peer-reviewed reference standards. Determinism and correctness are distinct properties. Both are required. Both are now confirmed in silicon, under documented test conditions, on production hardware.
The system is built using an architect-first methodology: all numerical constraints, compliance requirements, and system-level invariants are defined and documented before implementation begins. Tooling serves the architecture. The architecture does not emerge from the tooling.
Compliance & Audit Documentation.
- Full source code (CUDA, CPU, embedded) — access restricted
- Build system and reproducible build scripts
- Compiler configuration and precision enforcement records
- Platform-specific implementations — not disclosed here
- Complete V&V test suite and execution logs
- Physics validation suite and benchmark comparison results
- Hardware configuration records (GPU/CPU targets)
- Deterministic reproducibility validation artifacts
- IEC 62304 Class C Design History Files (DHF-003 through DHF-006)
- ISO 14971 risk management file with quantified risk scores
- EU MDR Annex II technical documentation mapping
- Post Market Surveillance Plan
- Software Bill of Materials v2 (NTIA format)
- STRIDE Threat Model Report (FDA Cybersecurity Guidance 2025)
- Requirement → implementation → test trace matrix
- Binary-level precision audit results
- API documentation — full codebase
- Software Tool Validation Index (STVI)
- Error bounds and numerical behavior documentation
- Versioned build artifacts corresponding to test runs
Structured Disclosure for Qualified Parties.
Request a Technical Brief
Full system architecture, algorithmic implementation, source code, compliance documentation package, and confirmed V&V results are maintained in a controlled disclosure environment — not present on this website. Access is structured to protect proprietary implementation detail while enabling genuine technical and regulatory evaluation.
Engagement types: technical evaluation, compliance review, licensing, government contracting, and investment due diligence.
Lucas J. Cannon
Founding and Managing Member
ChirpPoint Dynamics, LLC