8/21/2023 0 Comments En iso 13485 2016Although ISO 13485:2016 is not mandatory for EU MDR/IVDR compliance, it is a commonly acknowledged standard to demonstrate the compliance to the MDR/IVDR requirement of having a QMS implemented. ![]() On the 9 th of September, the European standardisation bodies CEN and CENELEC published the 2021 amendment, EN ISO 13485:2016+A11:2021 – ‘Medical devices – Quality management systems – Requirements for regulatory purposes’, featuring new annexes ZA and ZB that link the requirements of the Medical Device Regulation (MDR, EU 2017/745) and the In Vitro Diagnostics Regulation (IVDR, EU 2017/746), respectively, to specific clauses of the standard.ĮN ISO 13485:2016+A11:2021 provides regulatory requirements for the manufacturer’s Quality Management System (QMS) that ensures consistent design, development, production, installation, and delivery of medical devices.
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |