What is EN ISO 13485:2012/AC:2013 ?

EN ISO 13485:2012/AC:2013 and EN ISO 13485:2012+AC:2016 are two international standards that are essential for the medical device industry. These standards provide a framework for organizations to demonstrate their ability to provide medical devices that consistently meet customer and regulatory requirements.

EN ISO 13485:2012+AC:2012 is an international standard that specifies requirements for a quality management system specifically for medical devices. It is based on the ISO 9001:2008 process approach model for quality management systems and includes additional requirements specific to medical devices, such as risk management, traceability, and validation of processes.

The primary purpose of EN ISO 13485:2012+AC:2016 is to harmonize regulatory requirements for medical device manufacturers in order to ensure the safe and effective performance of medical devices. It helps organizations identify and address potential risks, increase efficiency, and minimize errors and defects throughout the entire product lifecycle.

EN ISO 13485:2012+AC:2016 is an essential standard for medical device manufacturers, as it outlines the requirements for a quality management system that consistently meets both customer and regulatory requirements. By implementing the requirements of EN ISO 13485:2012+AC:2016, organizations can demonstrate their commitment to quality and their ability to consistently provide safe and reliable medical devices.

In conclusion, EN ISO 13485:2012/AC:2013 and EN ISO 13485:2012+AC:2016 are two important international standards that serve as a framework for medical device organizations to establish and maintain a comprehensive quality management system that consistently meets customer and regulatory requirements. These standards are essential for ensuring the safe and effective performance of medical devices and for improving overall business performance.