A sustainably structured and certified quality management system in accordance with ISO 13485 not only helps to control and improve your company, but also to secure it's existence in the long term. You control the quality.


We focus on your demands.

Do you need an updated Clinical Evaluation according to current regulations?

Are you planning to obtain a CE-mark for your medical device for the European market?

Do you need additional human resources?

Has the Notified Body revealed any deficiencies concerning your documentation?

Are you looking for regulatory and clinical affairs support?

Are you looking for external know-how and independent expertise?


We have been working in the field of regulatory affairs and quality management since 2004. Benefit from our years of experience.

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We live quality and the requirements of ISO 13485, as well as the requirements of Regulation (EU) 2017/745. We are happy to work with your SOPs / templates on request.

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Our team supports you in different areas of quality management: strategic planning of the QM system, creation of the manual, joint development of procedural instructions, independent implementation of internal audits, training, support in audits of your notified body.


According to your needs, our quality management activities include the following steps.


Strategic planning

First, we work with you to define the strategic approach together with you and agree on a timeframe, including any timelines so that the process is completed in time for any deadlines. In this phase, we will exchange all necessary information.


Quality Management Manual

The quality management manual is the backbone of your QM system on which we work together with you and define a quality policy and goals.


Documented Procedures

For various processes we help you with the documentation of the process flows. According to your needs. Most of the processes also include appropriate templates that we can develop for you.


Internal audits

Your system lives on improvement. In order to regularly check where there is potential for improvement, we help you with your internal audits.



Training is the beginning and end of any QM system. We make your team fit and are happy to contribute our expertise if a knot in your head has to be untied.


Audits & Inspections

The notified body or the authority is coming? We support you in the audit or during the preparation. Of course, we also support you in the processing of deviations.

Get in touch with our experts!

Do you have any further requests?


We will show you how to coordinate your processes and SOPs so that they are ideally interlinked without inconsistencies.