Centralize all your evidence
Connect policies, requirements, risks, tests and evidence in one system. Instantly see what's missing, who's accountable and what's ready for audit.
ISO 13485
IEC 62304
ISO 14971
MDR 2017/745
IVDR 2017/746
Your product evolves.
So does your compliance.
The continuous compliance platform that connects your tools, orchestrates your evidence and supports the development of your MedTech products.
Build compliance directly in the tools your teams already work in.
Free 30-min call · no commitment
They trust us.
+35 projects accompanied.
The problem we solve
Compliance, without the chaos
Requirements, risks, tests and evidence get scattered across teams and tools. Qapsule restores order so product, engineering and quality move together toward an audit-ready file.
Track compliance without spreadsheets
See compliance progress in real time, from requirements to evidence, without multiplying Excel files.
Get guided by real experts
Combine Qapsule's power with QARA PULSE expertise to accelerate your regulatory projects, secure your decisions and move confidently toward certification.
Qapsule connects
Compliance, wired into your tools
Evidence, tickets, and docs stay in the tools product, engineering, and quality already use. Qapsule plugs in natively.
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Jira
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Confluence
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GitHub
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GitLab
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Notion
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Google Drive
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SharePoint
Qapsule in action
Compliance that fits into your day-to-day
Qapsule plugs into your stack. Gaps are detected, you're alerted, you fix them, and Qapsule helps you update the documentary side.
Qapsule detects
A requirement with no linked test, a risk left unreassessed, missing evidence: Qapsule spots it across your tools and file.
Qapsule alerts you
You get an actionable alert with severity and context, before an auditor or notified body finds it.
Fix from your tools
Work in your usual flow: the compliance chain syncs back into Qapsule. Compliance fits your day-to-day without switching tools.
How it works
Your fastest path to compliance
Certified and CE-ready in structured weeks, not years of document chaos.
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Needs and flow mapping
We map your needs and flows: requirements, interactions and dependencies, for a clear view of the system to build.
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Guided remediation
We implement the recommendations from the mapping with Qapsule and our experts, to optimize your flows.
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Internal audit
A dry-run audit catches nonconformities before the real audit. No surprises on audit day.
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Certification & CE
You approach certification and CE marking with a solid, audit-ready file.
Why Qapsule
Why medtechs choose Qapsule
Guided journey
A step-by-step path tells you exactly what to do next, in the right order, including ISO 13485 and software lifecycle.
QARA expert support
Real regulatory and technical experts coach your team, not just another dashboard.
Real quality practice
Put in place the processes and habits that actually protect your device and your patients.
Centralized evidence
Policies, technical file, risks and proof in one place, always ready for audit.
Faster audit program
Speed up your path to certification and CE marking with an optimized process.
Clear next steps
Always know what's done, what's missing and who owns each task across QARA, tech and product.
Impact
Compliance that unlocks growth
Unlock EU markets
Reach customers and distributors who require MDR/IVDR and a certified QMS.
Reassure investors & partners
Show a mature regulatory posture before due diligence and strategic partnerships.
Reduce costs
Less document rework, fewer scattered consultants: structured compliance from day one.
Build real quality
Controls and processes that actually protect your product and your organization.
Targeted gains
What Qapsule changes
Sovereignty
A sovereign offering,
rooted in France
Hosted on OVHcloud. Your compliance data stays in France, on European cloud infrastructure built for digital sovereignty. Roots in French Tech Grand Paris.
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.