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
They trust us.
+35 projects accompanied.
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.
Why run an ISO 13485 / MDR internal audit?
ISO 13485 calls for planned internal audits to check QMS conformity and effectiveness, including applicable regulatory requirements (MDR/IVDR). Beyond the standard expectation, it is the best dress rehearsal before an external review or notified-body audit: you find gaps while there is still time to fix them.
What is the difference between an internal audit and a certification audit?
An internal audit (or one by a mandated third party) checks your system for you. A certification / notified-body audit is run by an accredited body and conditions the certificate or marking. A field internal audit anchored in medical software reduces day-J surprises.
Can you outsource an ISO 13485 / MDR internal audit?
Yes, and it is common to secure independence and a notified-body style reading. QARA PULSE works with BSI-certified auditors, focused on medical software and field evidence. You leave with prioritized findings and actionable watch-outs.
When should you schedule an internal audit before the notified body?
In practice, schedule the internal audit 2 to 3 months before a certification audit or notified-body review, so you have time to plan and close nonconformities. Too late, and action plans get improvised under pressure. QARA PULSE delivers a prioritized gap report, anchored in product / software — not an out-of-context checklist.
Ready to secure your next internal audit?
30 min to plan your next internal audit.