About

QARA PULSE

Compliance must no longer slow innovation.

Quality, regulatory, product and tech experts for CE marking of medical software and health AI systems.

30-minute call · no commitment

Why we exist

Compliance should serve
the people who care.

Medtech teams build to heal. Compliance should not slow them down. QARA PULSE exists so CE marking moves at the pace of the product.

What sets us apart

Three values.
One through-line.

Human, agile, strategic. Three ways to make compliance an ally of the product.

Human

Compliance that is understandable, right-sized, and owned.

We don't do it for you. We build it with you.

Agile

Living systems, able to keep up with the pace of products.

Compliance must never slow the roadmap.

Strategic

Regulation used as leverage, not as a constraint.

A decision tool, not a weight.

Proof

Credentials
that count

BSI auditors, Bpifrance DiagDM experts, and measurable results with medtech teams.

Internal auditors pool Certified by BSI Group

Referenced DiagDM experts Bpifrance

In 1 year

+35 projects accompanied
4 CE markings
6 internal audits
5/5 Google reviews

Testimonials

As an early-stage medtech startup, regulatory can quickly become a wall. Alexandra and QARA PULSE turned that wall into a roadmap. If you are a medtech looking for a regulatory partner, not just a vendor, go with QARA PULSE.

Neil Benhamou Co-Founder & CEO, MediVIE Tech

Floryan (QARA PULSE) is proof that QARA can be done with velocity and modernity. Very pedagogical, he adapted to our startup constraints to deliver fast and well, with tools that change the game.

Hanthony Biancotto Co-Founder & COO, Leopa

QARA PULSE delivers a clear answer by combining regulatory expertise, software know-how, and supportive, structured guidance. Their strength: automating and steering compliance without losing sight of how teams actually work.

Thierry Gricourt President, SAS SOCIALDREAM

This internal audit helped us see where we stood. I especially valued Floryan's timing and pedagogy with our team, as we were creating a medical device for the first time.

Yara Morete COO, MediVIE Tech

Alexandra Bonnet (QARA PULSE) guided us brilliantly through our IVDR compliance journey, from structuring our QMS to drafting the technical documentation for our platform.

Arnaud Sandrin Co-Founder & CEO, Aima

Alexandra (QARA PULSE) masters Jira and brings valuable improvements at the interface between QARA and development teams. Attentive, reliable, with a professional and thoughtful approach.

Adeline François VP QARA & Clinical, Avatar Medical

When we launched CardioCubz, compliance was going to be a structural challenge. Alexandra and QARA PULSE turned it into a competitive advantage: an operational Quality Management System, and a quality culture embedded across the team.

Marius Popescu Cardiologist & co-founder, CardioCubz

Floryan led the internal audit of our Quality Management System with real attention to detail and strong knowledge of software medical device standards. A demanding yet constructive exercise that genuinely helped us move forward.

Mélyna Koutima QA/RA Engineer, MSInsight

Working with Floryan sustainably improved our practices, without cookie-cutter methods. He evolves what already works without distorting it, and gives us the keys to grow more autonomous without losing our identity.

Chloé Linda QARA & PRRC Engineer, MediVIE Tech

Founders

The people who started
QARA PULSE

The team

Quality, product
and technical

Let's talk about your next step

30 minutes to see if QARA PULSE fits your regulatory need.