Your MD / non-MD status stays unclear, and every decision becomes a gamble.
Hesitation on status, MDR or IVDR class, CE marking pathway. Without a clear foundation, obligations, first steps, and priorities stay open.
Service · Regulatory strategy
The right regulatory course, before the file.
MDR/IVDR classification and CE pathway, clarified.
A prioritized roadmap before the file.
30-min call · no commitment
Trusted by MedTech teams.
+35 projects supported.
The problem we solve
Without a clear regulatory path,
every choice is a gamble
For manufacturers of software and AI systems in healthcare, the fog starts before the technical file: MD vs non-MD status still open, generic advice that doesn't fit the product, tech choices made without MDR/IVDR or AI Act safeguards. The stakes are the same: set the frame before the roadmap is built backwards.
Generic advice ignores your architecture, use cases, and maturity.
Every medical software product is unique: architecture, risks, maturity stage. A one-size model for all SaMD gives neither direction nor actionable priorities.
Tech moves ahead without MDR / AI Act safeguards, and the file costs you later.
Shipping fast without anticipation creates detours toward the technical file. Uses, data, product logic, and AI need to be challenged now, not after.
Our approach
We challenge in the workshop.
We formalize the report.
Two complementary levers: a session to set status, classification, and structural choices on your product, then a strategy report that locks the course before you commit file and teams.
How we deliver
The regulatory workshop
Challenge session (~2 h) with your product, tech, and clinical teams. We anchor the frame in your architecture, use cases, and maturity.
You leave with
The regulatory strategy report
A structured write-up: product analysis, target markets, operational recommendation, and the quality deliverables to build next.
This framing is the entry point to our Programme PULSE (CE marking offer).
They clarified their path with us
From confusion
to a trajectory
Alexandra (QARA PULSE) brought real clarity to our regulatory positioning. A highly professional, structuring exchange, adapted to our operational reality and proportionate for our organization.
As an early-stage medtech startup, regulation can quickly become a wall. Alexandra and QARA PULSE turned that wall into a roadmap. If you are a medtech looking for a regulatory partner, not just a vendor, go with QARA PULSE.
What comes next
From framing
to operational compliance
CE marking · Programme PULSE
ISO 13485 QMS, technical file and support through the notified body.
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 clarify your regulatory strategy?
30 minutes to set the right regulatory course.