What is an ankle brace certified as a medical device?
To obtain medical device certification for a product, strict adherence to standards is required in both the design and the manufacturing processes. This implies that one knows and understands the sourcing and technical characteristics of all its constituent parts, and that they are all compliant with the standards. In addition, it is essential to understand the supply chain to be able to certify component suppliers, and also to determine the product's characteristics over time. But at DECATHLON, we go even further. We carry out our own 'clinical trials' to be sure that our products provide the advantages that the customer expects.