Quality management system according to EN ISO 13485.
Understand, interpret and implement requirements of EN ISO 13485:2016 for the medical device industry.
The EN ISO 13485 is the basis for QM systems in the medical device industry. EN ISO 13485:2016 defines new requirements for medical device manufacturers and specifies the requirements of the predecessor standard. Get to know the structure and contents of EN ISO 13485:2016 and learn how to set up or adapt your QM system accordingly.