ISO 13485
ISO 13485 is a quality management system standard, which is intended for medical devices. According to Regulations 2017/745 (MDR) and 2017/746 (IVDR), manufacturers need to establish, document, implement, maintain, keep up to date and continually improve a QMS.
This is most conveniently performed by following ISO 13485, as it is harmonized with MDR and IVDR, meaning that it meets the applicable requirements of General Safety and Performance Requirements of MDR and IVDR.
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