A major milestone for IMT Innovations:
ISO 13485 Audit Passed in Record Time
Last week, we passed our final ISO 13485 audit in record time - with no major findings.
Our quality management processes, including those covering the manufacturing of our box ventilator platform, successfully passed the audit requirements.
A huge thank you to our regulatory and quality team and Beat Keller for the outstanding work - and also to the auditors from our Notified Body. The audit was professional, highly competent, and focused on what really matters: quality and patient safety.
Exceptional teamwork on both sides.
Is Europe becoming attractive again for medical device manufacturers? With efficient processes and competent, solution-oriented auditors like we experienced: we believe YES!



