ISO 13485 or ISO 9001

It is not a question of preference, but what the legal regulations are and what requirements must be met in order for a medical device to comply with its regulations. ISO 13485:2016 is a standard that is specific for Manufacturers of medical devices (Medical devices — Quality management systems — Requirements for regulatory purposes). Besides that, on the web pages of the European Commission (https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/medical-devices_en) are stated which standards are applicable for all types of medical devices. On that list, which has around 300 standards, only ISO 13485:2015 is the standard for the quality management system.

For more information, see following articles:

• How can ISO 13485 help with MDR compliance? - https://advisera.com/13485academy/blog/2020/03/09/how-can-iso-13485-help-with-mdr-compliance/

• EU MDR – Easy-to-understand basics - https://advisera.com/13485academy/what-is-eu-mdr/