About qcompetence

We see ourselves as a consultancy for medical device approvals (Regulatory Affairs), quality management and process management. Our solutions are no "paper tigers”. We provide solid and substantial contributions, enabling you to place your medical device on the market with a good conscience. Sustainable product quality increases the competitiveness of your business.

qcompetence GmbH was founded in April 2006 with the vision of being market leading service provider for the approval of medical devices in German-speaking regions.

qcompetence ...

focused on solutions

We develop customized strategies for product approval and process landscapes tailored to the particular needs and culture of your company. We develop a customized quality management system for you.

offers integrated consulting

Based on long-term experience, we offer competent, effective and reliable support for your regulatory affairs questions from one source.

is practice oriented

We offer proven experience and expertise. We integrate solutions e.g. for your quality management system that have already been successfully implemented.