The QMS exists on paper, not in the teams' daily work.
Procedures outside tools, fuzzy ownership, evidence impossible to find at audit time. A QMS that does not live does not protect.
Service · CE marking · Programme PULSE
From QMS to CE file,
through to the notified body.
ISO 13485 QMS and technical file, built with you.
Steering through notified body audit.
30-min call · no commitment
Trusted by MedTech teams.
+35 projects supported.
The problem we solve
A CE path outside the product
gets paid on audit day
For manufacturers of software and AI systems in healthcare, CE marking often stalls on a QMS that is too theoretical, a fragmented technical file, or a notified body audit discovered too late. The stake: build evidence with the product rhythm.
The technical file is rebuilt in a rush before filing.
IEC 62304, ISO 14971 risk, usability and cyber: without a through-line, every release widens the gap with the CE file.
The notified body arrives with no safety net, and the calendar slips.
Unanticipated questions, major gaps, costly back-and-forth. Without NB support, certification becomes a sprint you endure.
Our approach
We build with your teams.
The pathway holds through the NB.
Two Programme PULSE levers: expert accompaniment anchored in your stack and roadmap, and a documentation foundation ready for filing and audit.
How we deliver
Programme PULSE
Regular sessions with product, tech and quality. We structure the QMS, prioritize CE file evidence, and prepare exchanges with the notified body.
You leave with
An operational CE pathway
An actionable QMS, a technical file coherent with your software, and a clear audit plan through certification.
eQMS deployment (Notion, Atlassian, GitHub, GitLab) is a separate offer, often run in parallel with Programme PULSE.
They moved toward CE marking with us
From regulatory fog
to a file that holds
Alexandra Bonnet (QARA PULSE) guided us brilliantly through our IVDR compliance journey, from structuring our QMS to drafting the technical documentation for our platform.
When we launched CardioCubz, compliance was going to be a structuring challenge. Alexandra and QARA PULSE turned it into a competitive advantage: an operational Quality Management System, and a quality culture embedded across the team.
The logical next step
Around CE marking,
complementary offers
Regulatory strategy
Classification, gap analysis and MDR/IVDR/AI Act roadmap before you commit file and teams.
eQMS deployment
Digital QMS in Notion, Atlassian (Jira / Confluence), GitHub or GitLab.
Internal audit
ISO 13485, MDR / IVDR checkpoint to secure the rhythm before external review.
Qapsule
If the foundation is in place: continuous compliance in your tools (does not replace eQMS).
FAQ
The first questions we get asked.
What is the difference between Programme PULSE and Qapsule?
At QARA PULSE, Programme PULSE is expert accompaniment: regulatory strategy, QMS, CE file and support through the notified body. eQMS deployment (Notion, Atlassian, GitHub, GitLab) is a separate offer, often run in parallel. Qapsule is the continuous compliance platform connected to your tools. Together: experts who guide you, a system that stays.
Does Qapsule replace my eQMS?
No. Qapsule connects to your tools and eQMS (Notion, Atlassian, GitHub, GitLab, and more). It orchestrates evidence and traceability; it does not replace the quality system.
Which standards do you cover?
QARA PULSE covers ISO 13485, IEC 62304, ISO 14971, IEC 62366-1, MDR, IVDR and the AI Act, for medical software and health AI. Details are in What we cover.
Where should we start?
If QMS or the CE file is not structured yet: Programme PULSE. If you already have a foundation and need product rhythm: Qapsule. Often both, in that order or in parallel. A 30-minute call with QARA PULSE is enough to scope.
Ready to start your CE marking pathway?
30 min to see if a PULSE program meets your need.