The QMS lives in a different tool than your teams.
Double entry, diverging versions, weak adoption. Quality becomes a parallel layer, not the system of work.
Service · eQMS deployment
A digital QMS
in your tools.
Notion, Atlassian, GitHub or GitLab.
Accessible, living, audit-ready.
30-min call · no commitment
Trusted by MedTech teams.
+35 projects supported.
The problem we solve
A QMS outside the stack
does not survive releases
Product and tech teams abandon proprietary eQMS. Without anchoring in their tools (Notion, Atlassian, GitHub or GitLab), procedures and evidence disconnect from daily work.
Evidence does not keep up with release rhythm.
Without workflows in their tools, traceability is rebuilt the night before an audit. Too late, too fragile.
A cobbled eQMS is neither compliant nor validated.
A structured space in your tools, but out of compliance and without validation. We make it compliant and validated before the notified body.
Our approach
We deploy in your stack.
You keep a living QMS.
Two levers: deployment anchored in Notion, Atlassian, GitHub or GitLab, and an actionable quality foundation your teams can sustain day to day.
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Confluence
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Jira
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Notion
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GitHub
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GitLab
How we deliver
Deployment in your tools
Spaces, workflows, roles and evidence structured in the stack already adopted.
You leave with
A compliant and validated eQMS
A digital, documented, usable quality system: procedures, records, traceability and team rituals ready for ISO 13485 / MDR.
Often run in parallel with Programme PULSE (QMS, CE file, notified body), without being confused with it.
They anchored their QMS in their tools
From double entry
to a living system
Alexandra (QARA PULSE) has excellent command of Jira and proposes valuable improvements between QARA and development teams. Attentive, reliable, with a thoughtful professional approach.
Floryan (QARA PULSE) proves you can do QARA with velocity and modernity. Highly pedagogical, he adapted to our startup constraints to deliver fast and well, with tools that change the game.
The logical next step
Around eQMS,
complementary offers
Regulatory strategy
Classification, gap analysis and MDR/IVDR/AI Act roadmap before you commit file and teams.
CE marking · Programme PULSE
ISO 13485 QMS, technical file and support through the notified body.
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 deploy an eQMS in your tools?
30 min to scope your eQMS in your tools.