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
They trust us.
+35 projects accompanied.
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 are the steps of CE marking for medical software?
In practice: classification, an ISO 13485 QMS, technical documentation (IEC 62304, ISO 14971, usability, cyber, and more), clinical evaluation, then notified-body interactions when the class requires it. Programme PULSE structures the QMS and evidence with your product, engineering and quality teams through the NB audit.
When do you need a notified body for medical software?
Under the MDR, a notified body mainly steps in from class IIa (and above). Rule 11 classifies the software from intended purpose and how significant the information provided is: it can lead to I, IIa, IIb or III. At QARA PULSE, we often start on a class I trajectory to structure the QMS and evidence, then prepare the step up to IIa when the product and market require it, with the NB timeline planned early to limit findings and back-and-forth.
How long does CE marking take for medical software?
Per our commercialization guide (French PDF), class I / A often sits around 5 to 7 months. From class IIa / B, the path becomes a multi-year industrial effort (order of magnitude: 16 to 85 months depending on class), especially once clinical evidence and a notified body are in play. A scoping call helps estimate your trajectory without an unrealistic promise.
How much does CE marking cost for medical software?
Budget to first commercialization varies mainly with class: roughly ~€90–250k for class I / A, up to several hundred thousand euros or even over a million from IIa onward (software development included, overhead excluded). What weighs most is not documentation alone, but development, clinical / performance evidence, notified-body timelines and team effort. For detailed ranges and assumptions: download our commercialization guide (PDF, French).
Ready to start your CE marking pathway?
30 min to see if a PULSE program meets your need.