We design and manufacture all our products in compliance with DIRECTIVE 93/42/EEC 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.