MyFoot® meets all requirements of the (EU) 2017/745 Medical Device Regulation (MDR). As such, we offer safe and effective orthopaedic devices, CE-marked in the case of products in standard sizes and fully compliant with MDR prerequisites in relation to custom products.
Medical Device Regulation
All our devices have a class 1 MDR classification. The processes used throughout our organisation are set up in such a way as to ensure complete availability of the necessary technical documentation which, in the case of custom products, we can provide and archive ourselves. So, for each individual product, there is always a full record of materials used and suppliers contracted. One more token of our commitment to professionalism and the transparency of our production processes.
This way, MyFoot creates the conditions for added patient safety based on innovative medical devices that meet the requirements of all applicable EU standards.
Apart from this, MyFoot is also working on implementing the ISO 9001:2015 quality system which will help us gain insight in our status of quality management, allowing us to assess the extent of operational control we have over our processes and the presence of or potential for systematic product improvement in support of optimal customer satisfaction.
ISO 9001 is a standard, a system of guidelines. It is not a set of specific, binding procedures. It is a mirror of our organisation, enabling us to evaluate our ability to drive continuous improvement by measuring our performance in quality management.