A wrong number here
reaches a patient.
In healthcare + life sciences, a computation isn't an abstraction — it informs a diagnosis, a dose, a trial endpoint. The software behind it has to be reproducible, traceable, and defensible to a regulator and an ethics board. We serve the sector with software, not cranes : deterministic clinical + research compute on Heisen, patient/sample-data integrity, a medical-software verification posture, and HL7 FHIR interop. Same input, same result, audit-trailed, sovereign. The clinician owns the care ; we make the compute behind it trustworthy.
Deterministic
Clinical + research compute — same input, same result
21 CFR Part 11
Electronic-records + signatures posture
IEC 62304
Medical-software lifecycle posture
Sovereign
Canada-built, data stays in your control
Six exposures across the data + the compute.
Healthcare risk is patient + regulatory risk before it's anything else : a non-reproducible analysis, a data-integrity gap, a record that won't survive an inspection. The exposures below are what deterministic, audit-grade software exists to control — the software half of a clinical or life-sciences program done to the standard.
Non-reproducible clinical analysis
If an analysis informing a diagnosis or a trial endpoint can't be reproduced, it can't be defended to a regulator or an ethics board. Heisen is deterministic — same input, same result, with inputs + version pinned for replay.
Patient / sample-data integrity gap
A data-integrity gap is a patient-safety + compliance failure. The record is built to ALCOA+ — attributable, contemporaneous, original, accurate — so it holds up to an FDA or Health Canada inspection.
Medical-software lifecycle non-conformance
Software touching a medical decision falls under IEC 62304 + ISO 13485. We build to that lifecycle posture from the start, so the software doesn't fail the QMS audit it has to pass.
Interoperability failure
Health data that doesn't move cleanly between systems is a care-continuity risk. We build to HL7 FHIR so the data interoperates instead of stranding in a silo.
21 CFR Part 11 non-compliance
Electronic records + signatures in a regulated context must meet 21 CFR Part 11. Our software is built to that bar — controlled, audit-trailed, signature-bound.
Data sovereignty + residency
Patient + research data on a foreign-controlled platform is a privacy + sovereignty exposure. Heisen is Canada-built + sovereign — the data stays in your control, deployable in your environment.
Software-first. The compute behind the care.
Healthcare + life sciences is a software engagement for us — deterministic compute, data integrity, verification posture, interop. Six concrete fits.
Deterministic clinical + research compute
Reproducible analysis pipelines for clinical + research data — every transform recorded + replayable, defensible to a regulator or ethics board years later.
Patient / sample-data integrity
Data integrity built to ALCOA+ — attributable, contemporaneous, original, accurate, complete — so the record survives an FDA or Health Canada inspection.
Medical-software verification posture
Software built to the IEC 62304 + ISO 13485 lifecycle from kickoff — verification + traceability that passes the QMS audit, not bolted on after.
HL7 FHIR interoperability
Health-data interop built to HL7 FHIR — clean exchange between EHR, lab, and research systems instead of a brittle point-to-point integration.
Audit-trailed compliance record
21 CFR Part 11-grade electronic records + signatures — controlled, audit-trailed, signature-bound. The inspection file generated as the work happens.
Embeds into your EHR / LIMS
Heisen embeds by API into your existing EHR / LIMS / research stack — the deterministic + audit layer alongside your systems, data residency intact.
Healthcare & Life Sciences in the field
From sector context to the lifts we engineer — a look at where this work happens.
The standards we work to.
We build the software to the medical-software + data-integrity standards your program is inspected against. The care + the science are the practitioner's — we build the deterministic, compliant compute behind them.
Medical device software lifecycle
The lifecycle standard for medical-device software. We build to its verification + traceability posture from kickoff, so the software passes the lifecycle audit.
Medical QMS + risk management
The medical-device QMS + risk-management standards. Our software-development posture slots into an ISO 13485 quality system with ISO 14971 risk control.
Electronic records + signatures
The FDA standard for electronic records + signatures. Our software is built controlled, audit-trailed, and signature-bound to meet Part 11.
Health-data interoperability
The modern health-data exchange standard. Our interop is built to FHIR so data moves cleanly between EHR, lab, and research systems.
Data-integrity principles
Attributable, Legible, Contemporaneous, Original, Accurate + Complete, Consistent, Enduring, Available. The clinical + research record holds to ALCOA+ for inspection.
Canadian health-privacy law
The Canadian health-privacy frameworks. Our software is built to keep patient data compliant + resident, with sovereignty by default.
Software only. No cranes, no rigging here.
Healthcare + life sciences is a pure software engagement. Our three crane-lift pillars don't apply — the value is entirely in the deterministic, compliant software. Here's how each pillar applies, honestly, including where it doesn't.
Sealed plans + emergency response
Not applicableHeavy crane lifts don't apply to a healthcare software engagement — there's no crane pick in our scope here. The engagement is entirely the deterministic clinical + research software.
Distribution + training + implementation
Not applicableWith no crane lift in scope, CRANEbee lift simulation doesn't apply to this sector. Our modeling value is the reproducible clinical + research compute, not a crane study.
Distribution + advisory + training
Not applicableMurlink rigging doesn't apply to a pure software engagement — there's no physical handling in our scope for healthcare + life sciences.
Deterministic engineering platform
The whole engagement. Deterministic clinical + research compute on Heisen — reproducible analysis, ALCOA+ data integrity, IEC 62304 verification posture, HL7 FHIR interop — audit-trailed, plus Maxor Audit + Maxor Ground. Sovereign, Canada-built, data residency intact. Heisen embeds into your EHR / LIMS by API.
Clinical software that holds up at inspection.
For healthcare + life sciences, the engagement is the software — anchored on Heisen. We build deterministic, audit-grade software : same engineering posture, same team kickoff to go-live, sovereign by default. An analysis that returns the same result on re-run and a record that holds up when an inspector retraces exactly how a result was produced. Engineered in Canada, owned by you.
Heisen — our deterministic intelligence layer — is optional on any build: embed it or not, your call. Either way it plugs into a fresh custom app or your existing third-party software via API.
Deterministic clinical / research compute
Reproducible analysis pipelines — every transform recorded, version-pinned, replayable for a regulator or ethics board, not a black box that drifts between runs.
Data-integrity + compliance record
ALCOA+ + 21 CFR Part 11-grade records — attributable, contemporaneous, signature-bound — generated as the work happens, ready for an FDA or Health Canada inspection.
FHIR interoperability layer
HL7 FHIR interop that moves health data cleanly between EHR, lab, and research systems — sovereign, audit-trailed, data residency intact.
Scope your healthcare engagement.
Tell us the program, the data, and the regulatory + privacy obligation. A senior lead responds within one business day with a scoped engagement and a path to first deliverable.