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.
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!




