We design and manufacture all our products in compliance with European Regulation for Medical Device (MDR) 2017/745 and the following regulations:

EN ISO 13485:2016+A11:2021 Medical devices – Quality management systems – Requirements for regulatory purposes

EN ISO 14001:2026 Environmental management systems – Requirements with guidance for use

EN ISO 14971:2019+A11:2021 Application of risk management to Medical Devices.

ISO 10993.1:2009 Biological evaluation of Medical Devices.

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