ISO 13485:2016 is an international standard that specifies the requirements for a quality management system (QMS) specifically designed for the medical device industry. It ensures that companies involved in the design, production, installation, and servicing of medical devices consistently meet customer expectations and regulatory requirements related to safety and efficacy.

This standard focuses on risk management, process validation, traceability, compliance with statutory and regulatory requirements, and continuous improvement across the entire lifecycle of medical devices. ISO 13485:2016 certification demonstrates that an organization has implemented best practices in quality management tailored to medical devices, helping to ensure product safety and effectiveness