What we do

Capture it. Make it defensible. Then act on it.

One discipline, applied to the systems your business cannot afford to misunderstand. We move what your organisation knows from a place it can be lost to a form it can defend — and then to a form it can act on.

Regulated MedTech & life sciencesOne system at a timeYour cloud
The model

Three planes, one foundation.

Each plane is defined by what you are left holding at the end of it, not by the activity inside it.

01 · CAPTURE

Get the knowledge out while it still exists

From the source, from the written record, and from the people who hold the reasoning that was never written down. Deployed inside your own environment.

Instrument: IRIS
02 · VALIDATE

Turn it into something that survives inspection

Rendered as artifacts your auditors accept, with provenance on every statement and a named practitioner signing. Your reviewer reviews rather than authors.

Human in the loop, by design
03 · APPLY

Point it at the outcome you were blocked on

The migration that stops stalling, the submission that stops waiting, the audit you can answer, the automation that finally has something true to run on.

Where the value is realised

Capture → Validate → Apply · one foundation carries through

What your peers are working on

Six problems running in life sciences right now.

No client names and no case studies. These are the situations we see repeatedly across regulated MedTech, and the form the work takes when IRIS is pointed at one of them.

Commercial

Read the payer logic out of the platform that runs it

The situationTwenty years of claims and contract rules inside a billing platform. The two analysts who understand it are the same two keeping it running in production.
Pointed atThe source, the modification specs, and the analysts — in their own language.
An auditable specification of how the rules actually resolve — so the processing path can be automated against rules somebody has verified, and defended when the pricing is questioned.
Regulatory & V&VLead

Write FDA-ready documentation from the firmware that ships

The situationA submission waiting on design rationale that exists in two engineers and nowhere else.
Pointed atDevice software, the existing design files, and the engineers who wrote them.
DHF content, hazard analysis, FMEA and traceability with provenance on every line — and traceability that stays live as the code changes.
Modernisation

Delete the discovery phase of an ERP migration

The situationFifty-plus bolt-on applications around a two-decade-old instance, a handful of business analysts, and a multi-year programme resting on an as-is nobody has written down.
Pointed atBolt-on codebases — RPG, COBOL, Java, PL/SQL — reconciled against the modification specs, plus the base-configuration knowledge only the analyst holds.
A documented as-is and fit-gap input in weeks rather than months of workshops — and an as-is that stays current through the programme instead of ageing out in month four.
Quality & complianceLead

Make the quality system explainable before an investigator asks

The situationQMSR is in its first inspection cycle. Deviation routing and CAPA escalation live in code and in precedent, not in documents.
Pointed atThe quality systems, the workflow logic, and the QA veterans who apply the precedent.
Documented decision logic with provenance — continuous gap analysis instead of a pre-audit scramble, and an audit response assembled in days.
M&A and carve-outs

Understand an acquired platform before the people leave

The situationPost-close, orphaned systems, and the team that understood them falls outside the org chart within twelve months.
Pointed atThe inherited estate and the parent’s experts, while they are still reachable.
What it does, what it commits you to, and what breaks if you switch it off — so retire, replicate or rewrite is decided per module rather than assumed for the estate.
Key-person risk

Capture a retiring expert while they are still here

The situationOne person holds fifteen years of system logic. The knowledge still exists — it has exactly one point of access, and it is leaving.
Pointed atTheir reasoning, elicited conversationally and reconciled against what the system actually does.
A successor onboarded in weeks instead of a year — and a single-person dependency that stops being a board-level risk.
Every one of them, scoped the same way One system you nameSix weeksPOC at near-zero costYour cloudYour reviewer signs
The join

The questions that need three experts and a shared calendar.

No single function holds the answer, so today the decision waits for whoever happens to be free.

A supplier change

Can we do this, what does it oblige us to file, what does it cost. One question, three heads, and an answer that waits for whichever two are free on Thursday.

QualityRegulatoryCommercial

A 483 response

The finding spans manufacturing logic, quality workflow and design history. Four teams spend weeks reassembling what the organisation already knew.

ManufacturingQualityDesign

Day one after an acquisition

What does this platform do, what has it committed us to, what breaks if we switch it off. Three questions, three functions, nobody holds all three.

EngineeringLegalCommercial

The point is not that we know more than your experts. It is that your organisation stops depending on which two of them are free on Thursday.

Start here

The how is a conversation.

Thirty minutes to find where your knowledge risk is highest. If there is a fit, we start with a proof of concept on one system you name — at near-zero cost, in your cloud, with the deliverable assigned to you.

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