What is the difference between ISO and EN ISO 13485 ?

ISO and EN ISO 13485 are both used to ensure the safety and effectiveness of medical devices. However, the scope of each standard is distinct.

ISO 13485 is an international standard that focuses on the quality management system for medical devices. It outlines a set of principles and requirements for a comprehensive quality management system that includes various activities such as design, development, manufacturing, testing, and inspection. The primary objective of ISO 13485 is to ensure that medical devices meet the needs of patients and stakeholders while also ensuring the safety and quality of the medical devices.

On the other hand, EN ISO 13485 is a European standard that outlines the requirements for a quality management system for medical devices. It is based on the ISO 13485 standard and has been adapted to meet the specific needs of the European market. The primary objective of EN ISO 13485 is to ensure that medical devices meet the needs of patients and stakeholders while also ensuring the safety and quality of the medical devices.

Application and Certification Requirements

ISO 13485 and EN ISO 13485 both have their own unique requirements for application and certification.

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