Quality Management Represen­tative (QMR)

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Professional quality management for medical device manufacturers without their own quality management representative

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.
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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 usability 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.

 

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You don't have to do every­thing yourself: Conve­niently outsource the role of QMR to us

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.   

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We are your experienced external QMR according to ISO 13485

As your external quality manage­ment represen­tative, we take on the following tasks:

  • Professional preparation and support during audits
  • Complete review of your QM system for conformity
  • Coordination and monitoring of all neces­sary measures, from the definition of CAPAs 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

Contact us now to find out how we can optimally support you as an external QMR.

Contact us, we're happy to help!
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Phone

+49 7531 94500 20

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Further support for your quality manage­ment system

Development/Optimization QMS

Our experts help you to achieve a lean and ISO 13485-compliant quality management system without burea­ucratic frustration. 

 

Audits and Audit Support

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.

 

E-Learning/Seminars/Workshops

Want to gain more knowledge? Our custo­mized e-learning courses, seminars, and workshops are the key. 

 

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