Our customer CAIRE Health AI GmbH has successfully completed the surveillance audit by the Notified Body.
The result:
No major findings. No minor findings.
For a medical device company, this is a strong result — and it is especially meaningful in a surveillance audit.
Because in a surveillance audit, the focus is not only on whether processes exist and formally cover the requirements of ISO 13485.
The real question is:
Is the QMS actually being lived in the company?
Do the processes work in day-to-day operations?
Are responsibilities clear?
Are records created as part of normal work?
Or does the team have to search for evidence shortly before the audit?
This is exactly where the strength of the Easy13485 Makerspace comes into play.
The Easy13485 Makerspace is not an off-the-shelf QMS. It is set up individually for each customer — tailored to the company, the product, and the current development stage.
For CAIRE Health AI GmbH, the Makerspace naturally covers not only ISO 13485, but also the requirements of the MDR, usability engineering according to IEC 62366, and medical software development.
This is important because, as a medical device manufacturer, you do not work in ISO standard clauses:
You develop a product.
You make design decisions.
You evaluate risks.
You collect requirements.
You document changes.
A good QMS supports exactly this work — it does not stand next to it as an additional burden.
That is why the Easy13485 Makerspace is based on real company processes from 25 years of practical experience with medical device manufacturers.
All processes are designed to work in daily practice while fulfilling the requirements of the relevant regulations and standards — easily and as part of the normal workflow.
This means that many of the required records are created automatically because they are part of the company’s regular work.
That makes a surveillance audit significantly easier.
A surveillance audit without major or minor findings shows very clearly:
The QMS has not only been implemented.
It is being used.
Think. Sip. Comply.
Auditfestes ISO-13485-System – mit klaren Befunden und wirksamen CAPAs.
Komplexe Projekte stabil führen – bis Meilensteine wirklich erreicht sind.
Klinische Evidenz ordentlich aufbauen – passend zu GSPR und PMCF-Erwartung.
DHF/TF strukturiert aufsetzen – Lücken schließen, Nachweise finden. Prüffähige Struktur nach Anhang II.
Regulatory aus einer Hand – von Submission bis Change Control. Pragmatisch, fristgerecht und dokumentiert.
Schlanke Prozesse, die im Audit funktionieren – und im Alltag laufen.