Quality & standards
EN ISO 13485
In order to meet the highest of quality requirements for medical devices, our quality management system fulfils the statutory requirements of EN ISO 13485:2016 + AC:2018 + A11:2021 and is therefore certified according to EN ISO 13485.
BORT products are subject to stringent quality control, many of them have the CE marking, which guarantees that these products meet the basic requirements of a European Directive, e.g. the Medical Device Directive or Medical Device Regulation (MDD, MDR).
Caregora™ – The first quality selected, certified angora fibre
BORT CLIMACare® products are manufactured using raw angora wool humanely acquired by shearing angora rabbits.