Quality includes patient safety, product quality and compliance with regulatory requirements, internalities and procedures. Elos Medtech’s quality management system covers the processes and procedures that are needed for governance and control of the business according to current standards and regulations. This ensures that the quality of our products and services meets our customers’ expectations and can be reproduced and traced at any time.
Elos Medtech has a well-established quality management system and is certified according to ISO 13485 management system for medical technology products. Additionally, Elos Medtech complies with applicable requirements in international legislation and product safety standards, such as the medical device directive (93/42 EEC), FDA’s quality system regulations and harmonised standards for medical devices.
In case of a product failure, we offer a 10-year-warranty of all our prosthetic components both for Elos Accurate Digital Solutions and Cresco Prosthetic Solution. Any complaints should be sent to the place of purchase. The complaint should be sent with the failed product within 14 days from the event.
You can download the mandatory complaint form here.