Promise of quality
Quality standards for safety and performance
For our 3D-printed orthoses and prostheses, we pursue the highest quality standards. The safety and satisfaction of the wearer is at the heart of our work. In order to meet the requirements and the high safety standards in orthopaedic technology, we ensure the quality of our products during development and beyond. To achieve this, we take various measures along our digital process chain. In the following we would like to give you an understanding of these measures.
Within the product development phase, and partially for every individual item virtual load and function tests and their validation are the core of it all:
Virtual load and function tests
From the very first design, our products are accompanied by virtual load and function tests (finite element analyses). Based on current ISO standards and the human model, continuous virtual quality assurance guarantees the safety and performance of our individual devices - from the initial idea to the certified medical device.
Validation of the virtual test stands
The virtual load and function tests used for individual prostheses & orthoses of the lower extremities were developed together with partners. In order to guarantee that real load conditions are calculated by computer simulations, the models have to be validated. We work together closely with our partners and are in constant exchange with various expert groups. This not only allows us to continuously improve our products, but also our virtual test stands as well.
But these components are not all that is to our understanding of quality. This is just the base that we need to cover to provide you with a tested and safe product.
There are many more components that make up "quality by Mecuris":
> Close cooperation with users and expert groups
> Feedback and maintenance loops
> Certified service providers
> Quality controls along the digital process chain
> CE marking of individual 3D-printed medical devices
> The structure of a QM-System
More questions about Mecuris?