WeMed News

The new edition of the ISO 13485 standard was published on March 1 2016.
ISO 13485 defines the requirements for a quality management system designed to demonstrate an organization’s ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.

The new ISO 13485:2016 focuses on how companies should manage risk-based decisions related to purchasing, design, development, manufacturing, production control activities and other aspects of the quality management system.
WeMed is proud to report that as a first step, we are updating the Quality Management System (QMS) to the new ISO 13485:2016.

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