The internal audit stays a checklist outside product context.
Without software / AI and field evidence anchoring, the report reassures on paper and misses the gaps that matter under MDR / IVDR.
Service · Internal audit
An internal audit,
before the notified body.
ISO 13485, MDR / IVDR for medical software.
BSI-certified auditors, prioritized gap plan.
30-min call · no commitment
Trusted by MedTech teams.
+35 projects supported.
The problem we solve
Gaps cost you
on certification audit day
For manufacturers of software and AI systems in healthcare, an internal audit that is too light or too late lets ISO 13485, MDR / IVDR gaps through that get expensive in front of a notified body.
Timing is too tight before the certification audit.
Gaps found too late, improvised action plans, teams under pressure. An early internal audit secures the rhythm.
Gaps are neither prioritized nor actionable.
Long reports, little clarity on what blocks an NB. You need a useful ranking for product and quality.
Our approach
We audit with rigor.
You leave with a clear plan.
Two levers: a field audit led by BSI-certified auditors, and a prioritized report to secure ISO 13485, MDR / IVDR before external review.
How we deliver
The field internal audit
Framed scope, interviews, evidence review and QMS / file challenge. Focus on medical software and SaMD, at your teams' pace.
You leave with
An actionable report
Ranked gaps, priority recommendations and watchpoints before management review, filing or notified body.
Often after a Programme PULSE, to verify its effectiveness, or ahead of a certification audit.
They secured their audit rhythm with us
From the pre-NB rush
to a useful internal audit
This internal audit helped us see where we stood. I especially appreciated Floryan's timing and pedagogy with our team, for our first medical device creation.
Floryan led the internal audit of our Quality Management System with real attention to detail and strong knowledge of software medical device frameworks. A demanding but constructive exercise that truly helped us progress.
The logical next step
Around internal audit,
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.
eQMS deployment
Digital QMS in Notion, Atlassian (Jira / Confluence), GitHub or GitLab.
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 secure your next internal audit?
30 min to plan your next internal audit.