ISO 13485
Short definition
ISO 13485 is the international standard that sets out the requirements of a quality management system for organisations that design, produce or supply medical devices, for regulatory purposes.
In plain language
The current edition dates from 2016. Regulation (EU) 2017/745 requires manufacturers to have a quality management system, and ISO 13485 is the most common way of structuring and demonstrating it. In the classes that require a notified body, the body audits the system, and certification to the standard is common practice.