ISO 13485:2016 is an international standard that defines quality management systemrequirements for manufacturers of medical devices. The primary objective of thestandard is to facilitate harmonised quality management system requirements forregulatory purposes within the medical device sector. ISO 13485 containsrequirements that are essential for any organization operating at any tier inthe medical device and pharmaceutical supply chain. It is especially relevantto manufacturers that wish to demonstrate applicable regulatory requirements,and by organizations whose services support medical device manufacturers.
Benefits of ISO 13485
ISO13485:2016 promotes harmonisationof regulatory requirements for manufacturers of medical devices on aninternational scale. It incorporates many of the quality management principlesand delivers the benefits of an ISO 9001 based quality management system.
How We Can Help
Globus Certifications has rich experience in designing, developing and implementing ISO 13485 ready Management System from the bottom up to meet ISO certification requirement. Â If the organization already has an existing management system, we help you by integrating ISO 13485 system with your current system.
Our trained and experienced management system consultants assist an organization in designing, developing, and implementing ISO 13485.
Our 5 Step Process – Consulting to Facilitating Certification