We design and manufacture all our products in compliance with MDR 745 “European Regulation 1017/845” and the following regulations:

EN 14971:2012 Application of risk management to Medical Devices.

EN 12182:2012 General requirements and tests for products for people with special needs.

EN 1041:2013 Requirements for Medical Devices related to the information to be provided by the manufacturer.

ISO 10993.1:2009 Biological evaluation of Medical Devices.

EN ISO 17966:2016 Assistive products for personal hygiene that support users — Requirements and test methods