EN FR
Let’s talk
Fractional CTO · Interim CTO · Medtech

Your technical leadership, for as long as it takes. I help medtech leaders design, build and certify their software.

From product strategy to CE marking: software architecture, IEC 62304 / ISO 13485 compliance, MDR and FDA clearance. I speak your language — the boardroom’s and the engineering team’s alike.

Let’s talk about your product See my services
10
years in medical software, from prototype to certified product
10+
CE markings and 2 FDA clearances on medical device software
62304 13485
IEC / ISO, MDR & FDA — compliance as an engineering reflex
Rigour, evidenced

In the code as much as in the regulatory file.

I do not just supervise: I read the code, I trace the requirements, I hold the IEC 62304 life cycle end to end. Compliance is not paperwork produced after the fact — it is an engineering discipline, from the first line onwards.

  • Traceability requirements ↔ tests ↔ risks
  • ISO 14971 risk management built into development
  • Design history file ready for the notified body
Services

Three ways to work together.

Every engagement starts with a straight conversation about your situation. No price list: a setup that fits what is actually at stake.

02
Audit & advisory

Does your software have to pass CE marking?

A technical and regulatory audit of your medical software: IEC 62304 life cycle, risk management, design history file. I name the gaps and map the route to CE marking or FDA clearance.

03
Product delivery

A product to build from scratch?

I design and build your medical software — architecture, back end, imaging or health AI as the case demands — with a team I assemble and lead, through to a compliant product.

How I work

A simple framework, with no grey areas.

Step 01

Conversation

A straight 30-minute call to understand your product, your team and what is really at stake.

Step 02

Diagnosis

I examine what exists — technical, regulatory, organisational — and identify the real blocking points.

Step 03

Proposal

A clear engagement framework: objectives, scope, pace and terms. You know exactly what you are getting.

Step 04

Engagement

I get into the substance, alongside your teams, with deliverables and a direction held over time.

Let’s talk about your product

A credible peer, in the boardroom and in the operating theatre.

You are carrying a medical software product and looking for senior technical leadership — for a transition, an audit or a delivery. The first conversation is simple and commits you to nothing.

contact@houssamkarrach.com
Reply within 48 working hours

First and last name, the way you use them in a meeting.

A work address: the reply goes out by email.

The company behind the product. Leave it empty if the project has no entity yet.

Type of engagement

The product, what stage it is at — prototype, CE marking under way, already on the market — and what you want from me.

Your information stays confidential and is used only to get back to you.

Read it back before sending

This is exactly what will reach me. Nothing is sent until you confirm.

Full name
Work email
Type of engagement
Your message

Message sent, thank you.

I will get back to you within 48 working hours to set up a first conversation. Talk soon.