01Doxeva

Medical software that holds up in production.

Software architect for medical devices. I help MedTech teams build software that holds up all the way to production, with documentation that grows alongside the code.

Workshop to start with
02Who it's for

For the teams who build the device's software.

I work with your engineering team, alongside your quality and regulatory teams. I do not replace them.

Early-stage MedTech startups

A proof of concept or a first version, but no documented architecture and no industrialisation? We lay the foundations before they get expensive.

Products already on the market

The software runs, but architecture, testing or deployment can no longer keep up? We audit, then strengthen the weak points.

AI teams, from PoC to product

Your imaging model or LLM works in a demo? We integrate it into the product, test it and monitor it.

SaaS vendors without a security team

A customer security questionnaire, a move to health-data hosting, the US market? We build a documented security baseline, ready for audit.

03Blocking pointsBlockers

Five situations, five ways in.

The software moves forward, but something lags behind. We start with a short, fixed-scope workshop on the precise problem.

From Design to Production

Demo ≠ product

the algorithm works in a demo, not yet inside the product

From PoC to production workshop 3 days · from €2,900 excl. VAT
Design

Nothing is written

the code exists, but the architecture and its decisions live in the developers' heads

Software scoping workshop 2 days · from €1,900 excl. VAT
From Requirement to Tests

Everything by hand

requirements, tickets, code and tests are only linked by a spreadsheet

Tooling and workflow workshop 2 days · from €1,900 excl. VAT
From Release to Production

It breaks in production

the team moves fast, but architecture, testing and deployment no longer keep up

Architecture and production audit 4 days · from €3,900 excl. VAT
The whole branch

No security baseline

no security documentation, while customers or the standard require it

Security by design workshop 2 days · from €1,900 excl. VAT
04The path

A simple path, with no commitment up front.

  1. 01 30 minutes

    A thirty-minute call

    Your product, its stage, your team and your deadlines. Together we identify the situation you are in, and a written proposal follows within 48 hours.

  2. 02 2 to 4 days

    A short, fixed-scope workshop

    Two to four days on a precise problem: scoping, PoC to production, tooling, audit or security. Deliverables are agreed in advance, and the price is deducted from the engagement if it starts within 60 days.

  3. 03 Engagement

    Then the engagement, if it makes sense

    A Foundations engagement to set up architecture and tooling, then a few days a month to hold the course. The goal remains to make your team self-sufficient.

Documentation grows alongside the code. Documentation
Requirement
written once
Code
linked to the requirement
Test
linked to the code
Release
file up to date
05Services

A workshop to start. Then we build.

Workshops 2 to 4 days

Target one problem

from €1,900 excl. VAT

Six fixed-scope workshops: software scoping, from PoC to production, tooling and workflow, architecture audit, AI in development, security by design.

Choose a workshop
Foundations 10 to 20 days
The core of the work

Lay the foundations

from €9,500 excl. VAT

Quoted as a package, usually 10 to 20 days: architecture, split between the medical device part and the rest, tooling, CI/CD and security, set up with your team and documented in your own tools.

Discuss an engagement
Part-time 2 or 4 days / month

Hold the course

from €1,800 excl. VAT / month

Two days a month, or four for €3,600 excl. VAT: architecture and code reviews, technical trade-offs, support for the CTO and the team.

Request a quote
The six workshops
01 from €1,900 excl. VAT

Software scoping

2 days
  • Target architecture diagram
  • Split between the medical device part and the rest
  • Top 10 technical risks
  • 90-day roadmap
02 from €2,900 excl. VAT

From PoC to production

3 days
  • PoC review
  • Integration architecture (inference service, model versioning, monitoring)
  • Testing and evaluation strategy
  • Costed industrialisation plan
03 from €1,900 excl. VAT

Tooling and workflow

2 days
  • Tooling assessment
  • Requirements, tickets, code, tests and releases workflow
  • Design file template
  • Set up on a real feature
04 from €3,900 excl. VAT

Architecture and production audit

4 days
  • Report on 6 scored areas
  • 30- and 90-day action plan
  • Debrief with the CTO
05 from €1,900 excl. VAT

AI in development

2 days
  • Claude Code configured on your repository
  • 2 skills (traceability, design review)
  • Usage rules for health data
06 from €1,900 excl. VAT

Security by design

2 days
  • Threat analysis
  • Technical security requirements
  • Third-party component and vulnerability tracking

Also for SaaS vendors who must answer a customer security questionnaire.

06Scope

What I do, what I don't do

I do

MAIN
  • Architecture decisions, code and design reviews
  • Test strategy with the QA team, CI/CD, observability, production rollout
  • Software security by design
  • Support for the CTO and the team
  • Turning regulatory requirements into technical decisions, with the quality team

I don't do

OFF BRANCH
  • ISO 13485 quality system
  • Regulatory file and submission
  • Clinical evaluation
  • Replacing the quality and regulatory team

I work with your quality and regulatory teams, I do not replace them. For everything else, I point you to specialists: quality and regulatory, penetration testing, usability, design.

07Background

Houssam KARRACH

Software architect, founder of Doxeva. Ten years at OneOrtho Medical, from first commit to production.

10
years at OneOrtho Medical

Medical device software, from design to production.

“An architecture that holds up all the way to production, without slowing the team down.”
08FAQ

Still have a question?

Book a meeting

I handle architecture decisions, code and design reviews, test strategy with your QA team, CI/CD, observability, production rollout and software security by design. I do not run the ISO 13485 quality system, the regulatory file, its submission or clinical evaluation: for those, I point you to specialised partners.