What is EN ISO 13485:2012/AC:2016 ?

EN ISO 13485:2012/AC:2016 is an international standard that outlines the requirements for a quality management system specific to the medical device industry. This standard, which is based on ISO 9001, provides a framework for organizations to establish and maintain a comprehensive quality management system that consistently meets both customer and regulatory requirements.

EN ISO 13485:2012/A2:2019 is an international standard for quality management systems specifically designed for medical devices. It provides a framework for organizations to meet regulatory requirements and ensure the safety, efficacy, and reliability of their products in the healthcare industry.

EN ISO 13485:2012/A2:2019 is an essential standard for medical device manufacturers, as it helps organizations establish and maintain an effective quality management system that demonstrates compliance with applicable regulatory requirements. It also helps organizations in the medical device industry to effectively control their operations, minimize risks, and deliver safe and reliable products consistently.

The key requirements of EN ISO 13485:2012/A2:2019 include the following:

The organization must establish and maintain a quality management system that meets the requirements of ISO 9001 and applicable regulatory requirements.

The organization must ensure that its quality management system is regularly reviewed and updated to ensure that it remains effective and meets the changing needs of the organization.

The organization must identify and assess potential risks to product safety and effectiveness, and take appropriate measures to mitigate those risks.

The organization must ensure that its quality management system is integrated into all aspects of the organization, including product design, manufacturing, testing, and labeling.

The organization must maintain records and documentation that demonstrate compliance with the requirements of EN ISO 13485:2012/A2:2019 and applicable regulatory requirements.

In conclusion, EN ISO 13485:2012/A2:2019 is an essential standard for medical device manufacturers that outlines the key requirements for a quality management system that meets regulatory requirements and ensures the safety, efficacy, and reliability of their products. By implementing the requirements of EN ISO 13485:2012/A2:2019, organizations can demonstrate their commitment to quality and their ability to consistently provide safe and reliable medical devices.