Atmora Tech

Industry

Software clinicians trust and auditors accept

Clinical and regulated software built to pass an audit, not just a demo.

Context

Technology in Healthcare & Life Sciences

We build patient-facing services, clinician tooling, integration layers between hospital systems, and the data platforms that sit under research and pharmacovigilance work. Most engagements start at the integration boundary, because that is where the pain is: HL7 v2 feeds with site-specific Z-segments, a FHIR mandate from a national programme, and a PAS that will not be replaced this decade.

Regulated delivery changes the shape of engineering. We keep requirements, risk controls, test evidence and release records linked in the toolchain rather than assembled by hand into a binder the week before an inspection. If your product is a Class IIb device and you do not yet have a quality management system, software engineering is the wrong first purchase — get the QMS and a notified body route in place, then build. We will say that in the first call rather than the fourth invoice.

1.4M
HL7 and FHIR messages normalised per day across a 22-site estate
4 days
release validation cycle, reduced from six weeks, on a regulated product
99.98%
availability of an emergency department integration over 24 months

Challenges

What actually keeps this sector awake

Not generic disruption — the specific constraints that shape every technology decision here.

  • Integration debt at the HL7 boundary

    Each site sends a slightly different ADT feed, custom segments carry clinically important data, and the interface engine has 400 undocumented transforms. A FHIR mandate arrives and the honest answer is that nobody knows what the current messages actually contain.

  • Validation costs more than the feature

    Under GxP and 21 CFR Part 11 expectations, a two-day change can carry six weeks of documentation. Teams respond by batching releases into large quarterly drops, which raises risk per release and makes defects harder to isolate.

  • Software as a medical device classification drift

    A decision-support feature that started as a dashboard now suggests dosing. Under EU MDR that is a different class, a different clinical evaluation and a different audit. Classification is usually decided by a product manager who was not told.

  • Secondary use of data without breaking consent

    Research and analytics teams want the record; information governance requires pseudonymisation, purpose limitation and residency guarantees. Ad hoc extracts spread copies nobody can later account for during a data protection review.

Approach

How we address them

  • A FHIR facade over feeds you cannot replace

    We profile what your HL7 v2 traffic really carries, build conformant FHIR resources on top, and keep the legacy feed running underneath. Terminology mapping to SNOMED CT and LOINC is treated as a maintained asset with its own review cycle, not a one-off script.

  • Validated continuous delivery

    Automated installation and operational qualification evidence generated by the pipeline, requirements traced to tests to releases, electronic signatures where the regulation demands them. Release validation stops being a fortnight of screenshots.

  • Device-ready architecture and risk traceability

    Software safety classification applied per component, hazard analysis linked to mitigations that exist in code, and a technical file that stays current between releases. We flag when a feature moves you into a higher class before it ships.

  • De-identification and research data supply

    Pipelines that produce pseudonymised, purpose-scoped datasets with re-identification risk assessed, plus a request and approval workflow so every analytical copy has a named owner, an expiry date and a deletion job that runs.

Start a project

Tell us what is
breaking.

We reply within one working day, and the first call is with an engineer who would actually work on it — not an account manager. If we are not the right studio for the problem, we will say so on that call.

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