01
Assay developers
Analysis software and LIVD files for tests that run on partner instruments.
Healthcare / IVD Software
In vitro diagnostics software development
An IVD test is only as good as the software that runs the instrument, calculates the result and gets it into the customer lab's system. Agnotic Technologies builds that software for IVD manufacturers, with the design records, mapping files and connectivity kits that ship with every release.
Device software
Instrument and assay code built under IEC 62304
LIVD
Test codes mapped to LOINC for customer labs
Connectivity kit
Interfaces a customer LIS team can install
Trusted by global innovators
Industry Overview
What is IVD software development?
IVD software development is building the software an in vitro diagnostics manufacturer ships with its tests and instruments: instrument control and result software, assay analysis algorithms, LIVD files that map test codes to LOINC, and the connectivity kit customer labs install. Agnotic Technologies builds this software for IVD makers, with the design records their regulatory teams need.
Industry Challenges
Where does IVD software slow a launch or a field release?
The failure points we plan around, because each one either delays a submission or reaches a customer lab.
An assay algorithm changes after verification, and the whole instrument has to be tested again because the code is not separated.
Every customer lab maps result codes by hand, so the same test arrives in different LIS systems under different codes.
The connectivity specification is a PDF that does not match the shipped software version.
Nobody can say which instruments in the field run which software and assay versions when a fix is ready.
The operator manual describes screens from the previous release.
Field error logs and complaints are not linked to the software version that produced them.
Decision table
Which kind of IVD software are you building?
The software type decides how it is regulated, how much of IEC 62304 applies and what the customer lab receives. The regulatory position in each row is the usual starting point; your regulatory team confirms it for your device.
| Software type | Usual regulatory position | IEC 62304 involvement | What the customer lab receives |
|---|---|---|---|
| Embedded instrument control (motion, fluidics, temperature, detection) | Part of the IVD instrument, reviewed with the device | Yes, as device software, with the class set by the risk analysis | The instrument, its software and the operator manual |
| Result calculation and interpretation (curve fitting, cut-offs, flags) | Part of the test's intended use; every change goes through design control | Yes, and often the highest safety class in the system | Results, flags and interpretations on screen and in the export |
| Standalone IVD analysis software | Can be a device in its own right, outside the instrument | Yes | Installable software or a hosted service with its own labeling |
| Connectivity kit (ASTM or LIS2-A2, HL7 v2, POCT1-A) | Decided by the manufacturer's regulatory team, often device documentation or an accessory | Where it can change or drop a result | Interface specification, LIVD file and test messages |
| Field service and installation tools | Often outside the device, unless they change calibration or results | Only where they touch device behaviour | Nothing directly; your service engineers use them |
Our Approach
How should an IVD maker approach software for a new test or instrument?
Three decisions that make later assay updates and field releases cheaper.
Separate the assay from the instrument
Assay parameters and analysis modules sit behind a defined interface, so a new assay or a corrected cut-off does not force a full instrument regression.
Publish mappings as data
Each software and assay version ships with its LIVD file, generated from the same source as the instrument's test menu, so labs receive codes that match what the instrument sends.
Treat the installed base as a record
Serial number, software version and assay versions for every instrument in the field, updated by the update package itself.
Capabilities
What do we build for IVD manufacturers?
Software we build alongside your engineering, assay and regulatory teams.
Instrument software and operator UI
Run control, sample tracking, quality control screens and result review on the instrument.
Assay analysis modules
Curve fitting, cut-offs and flags as versioned modules with their own verification.
LIVD file generation
Vendor test codes mapped to suggested LOINC codes, produced per software version.
Connectivity kit
Host interface drivers, the specification and a set of test messages for customer LIS teams.
Software update packages
Signed packages for field updates, with version checks and rollback.
Installed base registry
Which instrument runs which software and assay versions, at which site.
Field data feeds
Instrument error logs and events routed into complaint handling with the version attached.
Design history support
Requirements, risk controls, tests and releases traced in the records your QMS keeps.
Engineering Stack
Which standards does IVD software work with?
The standards we build to, and the platforms we build on.
Lab messaging
ASTM and CLSI LIS2-A2 host interfacesHL7 v2 result messagesPOCT1-A for point of care devices
Terminology
LOINCHL7 LIVD mapping filesUCUM units
Engineering process
IEC 62304 software life cycleISO 14971 risk managementRequirements to test traceability
Platforms
Embedded Linux or Windows IoTC, C++ and C# instrument codeCloud services for fleet data
Measured Impact
What should an IVD software program track?
Measures we report on release by release.
Versions
Installed base
Instruments on each software and assay version, by region.
Mapping
LIVD coverage
Tests on the menu with a published LOINC suggestion.
Interfaces
Connection defects
Issues raised by customer LIS teams per release.
Field
Version-linked issues
Error logs and complaints tied to the software that produced them.
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Use Cases
Which IVD teams work with us?
Manufacturers at different stages, from first instrument to a large installed base.
02
Instrument makers
Embedded control, operator UI and the host interface.
03
Point of care device makers
Device software and POCT1-A connectivity for clinics and wards.
04
Molecular diagnostics startups
A first instrument release with records ready for review.
05
Established IVD manufacturers
Connectivity kits and update tooling for a large installed base.
06
Lab automation vendors
Software that moves samples and results between instruments.
Integrations
Which systems does IVD software connect to?
The systems on both sides: your company and your customer labs.
Orders and results
Customer LIS
Rules and routing
Laboratory middleware
Connectivity validation
LIS test environments
Field issues
Complaint handling system
Installed base
ERP and service systems
Updates and logs
Device cloud
Compliance-First Development Services Backed by Global Standards
We build secure, scalable products designed for privacy, interoperability, and regulatory readiness from day one across every sector we serve.
Quality Management Systems
Ensuring consistent quality in software delivery and operational process optimization.
Fast Healthcare Interoperability Resources
Enabling standardized health data exchange through standards-based API mappings.
Health Level Seven International
Supporting enterprise-grade interoperability for clinical messaging and record workflows.
Our Edge
Why Global Leaders Choose Us
We combine deep technical expertise with industry-specific knowledge to deliver solutions that aren't just functional, but transformational.
Enterprise-Grade Security
We implement rigorous security protocols and compliance standards (HIPAA, GDPR, SOC2) across all industrial solutions to protect sensitive data.
High-Performance Scaling
Our architectures are built to handle massive data loads and user bases, keeping performance steady whether you're serving ten or ten million.
Accelerated Time-to-Market
Using our suite of internal tools and proven frameworks, we cut setup work so your first release reaches users sooner.
Embedded AI Integration
Beyond simple wrappers, we build deep-learning integrations and predictive analytics directly into the core of your industry-specific workflows.
Engagement Model
How does an IVD software engagement work?
We work inside your quality management system. Timing depends on scope; we agree a fixed first release on the scoping call.
01
Scoping call
We review the instrument, the assay menu, the target markets and the software records you already hold.
02
Software plan
Development plan, safety classification inputs and traceability set up in your QMS tools.
03
First release
One instrument function or assay module built, verified and documented end to end.
04
Connectivity and mapping
Host interface, LIVD file and test messages prepared with your field applications team.
05
Release and sustain
Update packages, installed base tracking and fixes under change control.
Facts and sources
Which rules and standards shape IVD software?
Short facts we design the software and its records around, each linked to its primary source.
FDA defines in vitro diagnostic products as reagents, instruments and systems intended for use in the diagnosis of disease or other conditions, used in the collection, preparation and examination of specimens taken from the human body, and treats them as devices.
Source: 21 CFR 809.3(a) (eCFR)IVD labeling for instruments must state the use or function, installation procedures, principles of operation, performance characteristics and specifications, operating instructions and calibration procedures, among other items.
Source: 21 CFR 809.10(b)(6) (eCFR)The HL7 LIVD implementation guide gives an industry standard way for an IVD manufacturer to publish suggested mappings from a device's proprietary test codes to LOINC codes, for the LIS analyst who connects and configures the device.
Source: HL7, LOINC/IVD Mapping (LIVD) FHIR implementation guideFDA's June 2023 guidance on premarket submissions for device software functions sets two documentation levels: Enhanced, where a software failure could present a hazardous situation with a probable risk of death or serious injury, and Basic for all other submissions.
Source: FDA, Content of Premarket Submissions for Device Software Functions (June 2023), section V
Voice of success
We don't just build products; we forge lasting partnerships. See how we've helped industry leaders transform their vision into technical reality.
“I can clearly see how Agnotic has a unique way of handling end-to-end development. They are always active on quick chat and provide support quickly.”
Aaron Phelan
Founder, Benchmark
“Agnotic combines deep technical expertise with strong domain knowledge. They understand the business context, anticipate challenges, and make collaboration smooth and effective.”
John Pasmore
Founder, Latimer
“Agnotic is the best technical team we evaluated. Their engineering excellence made our work dramatically easier and allowed us to stay focused on what matters most for maternal care outcomes. They took full ownership of the technical execution, and we are always happy to continue working together.”
Kim Smith
Founder, My Lauren
Related services
Related laboratory and device software
This page covers what the IVD maker ships. These pages cover the lab side and the device rules around it.
Medical laboratory instrument integration
Connecting analyzers to a lab's LIS, middleware rules and go-live testing.
Laboratory information system development
The LIS the customer lab runs.
Medical device software development
Device software, companion apps and connected platforms.
FDA SaMD compliance
Classification and submission for software as a medical device.
Medical device complaint handling software
Intake, investigation and reporting of field complaints.
Medical device software sustaining engineering
Keeping released instrument software current and safe.
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Cross-Industry Reach
The Same Engineering Patterns, Across Other Industries
The technical patterns behind this platform translate naturally into adjacent verticals.
Frequently Asked Questions
That is a regulatory decision for your team, and it depends on whether the kit can change, drop or misroute a result. We document the kit to the same standard either way, with its specification, test messages and the LIVD file for each version.
An LIVD file is the manufacturer's published suggestion of which LOINC code fits each of its test codes. You own and maintain it; we generate it from the same source as the instrument's test menu so it changes when the menu changes.
Yes. We follow your software development plan and safety classification, keep requirements, risk controls and tests traced, and hand over the records into your QMS. We do not certify devices; your regulatory team and reviewers decide.
We produce the software inputs both need: architecture, verification, risk and labeling content. Your regulatory team assembles the technical documentation for the IVDR and the FDA submission, and decides the classification in each market.
With signed update packages that check the instrument's current version, record the result in the installed base registry and support rollback. Rollout can be staged by region or site, and every update is traceable to its change request.
It depends on the instrument, the assay menu and the markets. We agree a fixed first release on the scoping call, usually one function or assay module verified end to end, and give you a timeline for it.
Yes. We test the host interface against the LIS and middleware environments your field applications team uses, and keep the test messages as part of the connectivity kit.
Industries