Developer at three monitors with code and an MR brain image

Radiotherapy manufacturers whose plans move between systems without manual repair.

Treatment planning systems, linear accelerators, oncology information systems and contouring products sit in IEC 62304 software safety class (A, B or C, by the harm a software failure could cause) B and C, and their plans have to import cleanly at every clinic's oncology information system. The release date is fixed and the scope keeps growing. We add engineers where the bottleneck is, in development, in verification or in the documentation, inside your lifecycle and quality system, for the EU MDR and the FDA.

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Systems: TPS · OIS · contouring · DICOM RT
Standards: IEC 62304 · ISO 13485 · IEC 62083 · EU MDR · FDA
First step: Free 30 minute call with engineering

The software path

How a planning software change reaches the clinic.

Requirement

The release date is fixed, the scope grows, and plan exchange changes and defects wait for the same engineers.

ImprovementOur engineers join where the bottleneck is, in development, verification or documentation, and work to your release plan.

Design

The import and export of RT objects are designed after the module, and the next system reads them differently.

ImprovementThe import and export of each RT Structure Set, RT Plan and RT Dose object is designed together with the module that writes it.

Implementation

New engineers need months before they can change planning code safely.

ImprovementOur engineers start with a small work package under your review, so you judge their code before the team grows.

Verification

Regression and interface tests run late, so verification is behind development before every audit.

ImprovementRegression and interface tests run in the pipeline on every change, so the records exist when the work is done.

Release

A change without its risk assessment stops the release at the gate.

ImprovementEvery change carries its safety impact analysis, as IEC 62304 asks, so the release record is complete at the gate.

Field support

A plan exported from your system fails at a clinic's oncology information system, and the failure is hard to reproduce.

ImprovementWe reproduce the failure from the site's export and add the case to the interface tests.

Change

A new DICOM RT version or OIS interface leaves the conformance statement and the tests out of date.

ImprovementThe conformance statement and the interface tests are updated in the same change.

The goal

Planning software released to plan, with plans that import at every clinic.

For the manufacturer

Planning releases with a complete verification record
Plan exchange that works with the oncology information systems at your clinical partner sites
One quality system for the auditor to read

For physicists, dosimetrists and oncologists

Contours, plans and dose objects that import and export without manual repair
Planning software that behaves the same after an update
Auto segmentation results that arrive as editable contours

For patients

Better treatment sooner, because new planning features reach the clinic on time
Defects in planning software fixed quickly
A plan that reaches the linear accelerator exactly as it was approved

Problems and solutions

What we hear, and what we do about it.

The release date or the scope is fixed, and the product team is already full.

Our engineers join where the bottleneck is, in development, verification or documentation, and work in your lifecycle and review workflow. Every change is recorded with its requirement and risk assessment. When the scope grows, the team grows by another work package.

Team extension

Contouring algorithms from research partners run on a workstation, and the clinics cannot use them.

We host the algorithm as an isolated service with a secure DICOM path to PACS (the image archive). The contours leave as RTSTRUCT, which the planning system imports as editable contours, or as DICOM SEG where the receiving system supports it. We write the documentation for the technical file.

From AI model to medical device

A plan exported from our system fails at a clinic's oncology information system.

We write the import and export of RTSTRUCT, RTPLAN and RTDOSE together with the module, and we write the conformance statement. Plan transfer and treatment records are tested against exports from the planning and oncology information systems at your clinical partner sites.

Interoperability

Verification falls behind development before every audit.

We build regression tests, interface tests and traceability from requirement to test result into the pipeline. The auditor then reads records that were made during the work.

QA, compliance and regulatory support

Engineers who do not know planning code will damage it.

Your procedures, review workflow and release gates stay in place, and our engineers work inside them. Every change is traced from the first line of code. The first work package is small, so you judge the result on real changes before the team grows.

How we work

Security patches for installed planning systems wait behind feature work.

Our engineers harden the software and handle the vulnerabilities inside the same lifecycle as the planning code. Each patch goes through your change control with its risk assessment.

Medical device cybersecurity

We will depend on an outside team for code only they understand.

Code, tests, design documents and records are written in your repositories and your templates, and your own developers review every change.

Dedicated engineering teams

Systems

The systems around a planning product, and the interfaces between them.

System	What it holds	Interface and standard	Our work
Treatment planning system	Contours, plans and dose objects	DICOM RT · IEC 62083	We build new planning features inside an existing TPS, or a standalone module that exchanges plans with one.
Dose calculation	Dose distributions for a plan	IEC 62083 · RTDOSE	We integrate dose engines, improve their performance and run regression against reference dose distributions.
Plan optimisation	Beam and fluence parameters	RTPLAN · RTDOSE	We build inverse planning for IMRT and VMAT with dose volume objectives and constraints, and plan evaluation with DVH.
Contouring and auto segmentation	Structure sets and model results	RTSTRUCT · DICOM SEG · EU AI Act	We build contour editing tools, integrate and host auto segmentation models and keep model version control.
Planning images	Planning CT and MR	DICOM · DICOMweb	We build the image import and the path to and from PACS.
Plan exchange	RT Structure Set, RT Plan and RT Dose between systems	DICOM RT · IHE-RO	We write the import, the export and the conformance statement, and test against exports from the systems at clinical partner sites.
Oncology information system	Approval status, treatment records, record and verify	DICOM RT · HL7 · IEC 62274	We exchange plan transfer, approval status and treatment records with the OIS.

Fit

When we are the right partner.

Call us when

You want more engineers for the next planning release who already work under IEC 62304, on products built to IEC 62083
You want a research contouring algorithm running as a regulated service next to PACS
You want plans from your system to import without manual repair at every clinic's oncology information system
You want verification to keep pace with development before the next audit

Talk to us

Tell us what you are working on.

A planning feature, a contouring module, a DICOM RT interface or verification before an audit. Write a few lines, or book a free 30 minute call with engineering.

Book a 30 minute technical call

FAQ

Frequently asked questions.

Can your engineers work inside our IEC 62304 lifecycle and ISO 13485 QMS from the first change?

Yes. They follow your procedures, templates and review workflow. Every change carries its requirement, risk assessment and verification, and the records are made in your system, so the auditor sees one quality system.

Can you build a contouring module that integrates with existing radiotherapy systems through DICOM RT?

Yes. We specify and build the module and its DICOM RT import and export (RT Structure Set (the DICOM object that holds the outlined organs and target volumes), RT Plan, RT Dose and registration objects). We write the DICOM conformance statement and test against exports from the planning systems and oncology information systems at your clinical partner sites.

Which standards apply to treatment planning software?

IEC 62304 for the software lifecycle, ISO 14971 for risk management, IEC 62366-1 for usability and IEC 62083 for the safety of radiotherapy treatment planning systems. EU MDR applies in Europe, and the FDA premarket requirements apply in the US.

Do you build auto segmentation models?

Yes, when you have the data to train them on. We train and validate segmentation models on your data, or take your existing model, and build the product around it. That covers the inference service, the DICOM RT export of the contours, model version control and the evidence for the technical file.

How does a first engagement start?

With a technical call. Then we agree on the first step: one or two engineers who join your team, a defined work package, or an IEC 62304 gap analysis (a review of what is missing against the standard). The team grows in small steps as the work needs it. Each step is quoted individually and agreed in writing.

Related services and sectors.

Team extension Dedicated engineering teams Medical and dental imaging software AI model to medical device Interoperability Medical imaging OEMs Radiotherapy and oncology centres