Radiology
Imaging triage, segmentation, reporting copilots
Engineering
the AI behind
clinical-grade products.
A small, senior engineering firm partnering with healthtech and life-science teams to design, build, and ship AI systems and Software as a Medical Device — with the regulatory rigor clinics require.
12 models
in clinical production
§ 01Manifesto
Most AI never reaches the patient. It stalls in pilots, fails audits, or breaks the workflows it was meant to support. We exist to change that — by engineering AI and medical software with the rigor clinics expect and the pragmatism teams need to ship.
§ 02Services
Two practices.
One engineering standard.
§ 03Capabilities
A team that ships across the AI & software stack.
LLM systems
Clinical AI
Data & MLOps
Product engineering
Architecture & audits
Regulatory engineering
§ 04Industries
Where our work lands.
Pathology
Whole-slide imaging and workflow integration
Cardiology
Signal processing, arrhythmia, monitoring
Genomics
Variant pipelines and clinical reporting
§ 05Why Insolitech
Built to be trusted in clinic.
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I.
Senior-only delivery.
The engineers in your meetings are the engineers writing the code. No layered subcontracting, no junior handoff.
II.
Regulatory fluency.
IEC 62304, ISO 14971, FDA, EU MDR — built into our process, not bolted on at the end.
III.
End-to-end ownership.
Discovery, architecture, models, integration, deployment, and the documentation your auditors expect.
§ 06How we work
A process built for clinic.
Discover
We map the clinical and technical problem, constraints, and success metrics.
Design
Architecture, risk analysis, and a plan that holds up to audit and reality.
Build
Senior engineers deliver in tight iterations with traceable artifacts.
Ship
Validation, deployment, and documentation your team and regulators need.
§ 07FAQ
Common questions.
- Consulting and feasibility work runs two to eight weeks. Custom builds typically run three to nine months depending on regulatory scope. Embedded engagements are open-ended.
- Yes. We frequently embed senior engineers alongside in-house teams, bringing AI and SaMD process on top of your existing engineering.
- You do. All code, models, and documentation produced for your project are yours, with clear assignment in our contract.
- We don't act as your regulatory affairs team, but we produce the engineering artifacts — design history, risk file, V&V evidence — your RA/QA function needs for FDA or EU MDR submissions.
§ 08Get in touch
Have something serious
to build?
Tell us what you're working on. A senior engineer reads every message and replies within one business day.