Quality Management Services

In the highly regulated medical device market, maintaining a quality management system according to EN ISO 13485 is key to ensure product quality.

It is our aim to establish a lean, dynamic and user friendly quality management system for you as our customer. A system that you are able to maintain without our support in the mid term  - we like to see our clients grow and prosper!

We gladly accompany you in any challenge arising in relation to medical devices, such as setting up a technical documentation, resolve audit findings and/or perform qualification/validation.