ISO 13485 – Medical devices – Quality management systems – Requirements for regulatory purposes

PROSYSTEM is an active member of the standardization committee ISO TC210/WG1 and thus is an author of the new ISO 13485:2016 (3rd edition). Receive your information at first hand and do not rely on information from the internet. Our consultants and project engineers assist manufacturers and suppliers of medical devices with the implementation of relevant requirements of ISO 13485.
In its Annex Z the EN ISO 13485 requires a complete quality management system. As the case may be the requirements of EN ISO 13485 alone can be insufficient to cover additional requirements of European directives. Contact PROSYSTEM today to inform yourself about the Essential Requirements in order to secure a successful certification.