Regulatory requirements are slowing your product roadmap.
Each new MDR, IVDR, or AI Act requirement pushes a delivery out. Product and engineering move ahead, then stop to catch up on missing documentation and evidence.
Accelerate CE marking for your digital medical devices.
Build the innovation of tomorrow.
Experts who guide you.
A system that stays.
They trust us.
+35 projects accompanied.
The problem we solve
Compliance,
without slowing innovation
For medical device manufacturers, regulation often becomes a brake: dossiers pile up, teams stretch thin, and conformity stays fragile over time. Whether you need expert guidance or a system that structures your evidence, the goal is the same: move forward without rebuilding at every milestone.
Compliance burns your teams, without leaving a lasting system.
The same people carry design, quality, and audit. Without a shared method or tool, the effort repeats on every project and leaves nothing durable behind.
Audits and ongoing conformity remain a permanent risk.
Between audits, evidence drifts. Without continuous upkeep, the next review becomes a race against time, with a real nonconformity risk.
Our approach
We build with you.
The system stays.
To lift regulatory friction, two complementary levers: expert accompaniment carried with your teams, and a living system that structures compliance over time. Together, they form the foundation to move forward without rebuilding at every milestone.
Accompaniment
Programme PULSE
Accompaniment programme to secure strategy, quality and CE marking, at the pace of your product and tech teams. We build the journey with you, without slowing the roadmap.
System
Qapsule
Continuous compliance platform connected to your tools. Evidence and documentation at release pace. What you build does not vanish when the project ends.
Our services
Regulatory accompaniment,
at the pace of your roadmap
Our experts cover the critical medical device compliance milestones: strategy, CE marking via Programme PULSE, eQMS deployment and audits. A clear offer to move forward with your teams, without rebuilding at every step.
Regulatory strategy
Classification, gap analysis and MDR/IVDR/AI Act roadmap. Solid foundations before you commit file and teams.
CE marking
Technical file, ISO 13485 quality management system, and audit steering with the notified body. From filing to certification, within Programme PULSE.
eQMS deployment
Digital quality management system setup in Notion, Atlassian (Jira / Confluence), GitHub or GitLab. Accessible, living, and compliant.
Internal audit
MDR/IVDR and ISO 13485 audits by BSI-certified auditors. Anticipate gaps rather than endure them.
Our solutions
Continuous compliance,
in the tools your teams already use
Complementing expert accompaniment, Qapsule is QARA PULSE's continuous compliance platform. Evidence and documentation at release pace, connected to your stack, without slowing the roadmap. It does not add a silo: it orchestrates compliance around your tools and your eQMS.
Connects your tools
Jira, Confluence, GitHub, GitLab, Notion, Drive or SharePoint: Qapsule connects natively. Product and tech teams stay in their day-to-day workflow.
Detects and orchestrates
Requirement without a linked test, risk not reassessed, missing evidence: Qapsule spots gaps, alerts you, and helps keep the file current.
Continuous evidence
Policies, requirements, risks, tests and evidence linked in a living system. Audit-ready traceability, without scattered spreadsheets.
Follows product evolution
Every release feeds compliance. What you build with Programme PULSE does not vanish: the system stays at the pace of your roadmap.
About
Field experts,
one shared conviction
We bring together quality and regulatory, product and tech experts, with more than 10 years of experience in CE marking for software and health AI systems. We led the first CE markings under the MDR and IVDR regulations.
Driven by the same conviction: compliance must no longer slow innovation. It should structure it, so your teams can focus on what matters most.
Internal auditors pool Certified by BSI Group
Referenced DiagDM experts Bpifrance
Standards
What we cover
Standards and regulations at the heart of digital medical devices: quality, software, cybersecurity, risk, MDR/IVDR and AI. A clear framework to scope, build and maintain.
ISO 13485
IEC 62304
IEC 82304-1
IEC 81001-5-1
ISO 14971
IEC 62366-1
MDR
IVDR
AI Act
FDA
Results
What teams say
MedTech manufacturers looking for a regulatory partner, not just a vendor.
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.
Resources
Guides and landmarks
to move faster
Resources to structure your compliance and inform your decisions, helping you understand, anticipate and master your software compliance through analyses and methods designed to accelerate lasting conformity.
Analysis
Qapsule, a Ketryx alternative for SaMD
SaMD shortlist criteria: stack, eQMS in your tools, MDR/IVDR evidence. Market reference table included.
Analysis
AI Act and medical devices: what SaMD manufacturers should prepare now
How to connect the AI Act and MDR/IVDR without duplicating the file, by extending the existing QMS to data, monitoring and human oversight.
Analysis
PCCP and AI medical software: governing change without slowing the product
How to prepare a Predetermined Change Control Plan aligned with the QMS, software lifecycle and FDA / MDSAP expectations.
Article
IEC 81001-5-1 and MDR: folding cybersecurity into the software lifecycle
Connect threat modeling, SBOM and evidence to the technical file, so cyber is not an add-on outside the QMS.
Ready to accelerate your next step.
A call to scope your next regulatory step, without jargon.