Benefit from our extensive experience as a QMR for numerous manufacturers. We are familiar with the detailed requirements and avoid typical pitfalls from the outset.
We provide targeted support where you need it. No unnecessary meetings or processes. You only pay for what you really need.
Our experts are experienced auditors themselves and are fully familiar with the requirements of the authorities and notified bodies. We prepare you optimally for external audits.
From ETO sterilization to risk management and usability and clinical evaluation – we offer all the relevant expertise from a single source.
There is no need to worry about holiday or sick leave coverage: Our team ensures the continuous care of your QM system.
Our expertise and efficient approach will accelerate market access and avoid costly delays.
The QMR is the key figure for legally compliant processes in the company. Without an experienced QMR, there is a risk of regulatory problems and, in the worst case, even a marketing ban.
Especially as a small economic operator with limited internal resources, you are faced with the challenge of finding a competent quality management representative for your quality management system.
The search for such a QMR is time-consuming and costly. You may have already had negative experiences with a previous QMR or are under time pressure after a critical audit.
As your external quality management representative, we take on the following tasks:
Contact us now to find out how we can optimally support you as an external QMR.
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+49 7531 94500 20
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Our experts help you to achieve a lean and ISO 13485-compliant quality management system without bureaucratic frustration.
We review your management system with a trained external perspective. We help you eliminate any problems we find in a targeted manner. You will then be ready for audits by authorities and notified bodies.
Want to gain more knowledge? Our customized e-learning courses, seminars, and workshops are the key.