Quality Management Representative (QMR)
Professional quality management for medical device manufacturers without their own QMR
Decades of Expertise
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.
Customized Support
We provide targeted support where you need it. No unnecessary meetings or processes. You only pay for what you really need.
Audit Reliability
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.
Comprehensive Competence
From ETO sterilization to risk management and clinical evaluation – we offer all the relevant expertise from a single source.
Guaranteed Availability
There is no need to worry about holiday or sick leave coverage: Our team ensures the continuous care of your QM system.
Fast Market Access
Our expertise and efficient approach will accelerate market access and avoid costly delays.
You don't have to do everything yourself: Conveniently outsource the role of QMR to us
Especially as a small economic operator in the medical device industry with limited internal resources, you are faced with the challenge of finding a competent quality management representative for your QM 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.
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.
Regulatory certainty for your company: We are your experienced external quality management representative according to ISO 13485
As your external quality management representative, we take on the following tasks:
- Professional preparation and support during audits
- Complete inspection of the conformity and optimization of your QM system
- Coordination and monitoring of all necessary measures, from the definition of correction and preventive measures to their implementation
- Regular status reports to management as a basis for optimal decision-making
- Maintaining and continuously optimizing your QM system
- Competent communication with authorities and notified bodies
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