ISO 13485 the International Quality Management Systems for the design and manufacture of medical devices.
Helps you with
Quality Control, Risk Management, Legal Compliance, Traceability and Recall, Process Improvement, Product Improvement, Operational Efficiency
Please note: You can still apply for either 2012 or 2016 versions of ISO 13485. Certificates issued for 2012 version will have validity up to the end of the transition period (March 2019). Learn more about the changes to ISO 13485 here.