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What is the current version of EN ISO 13485?


The EN ISO 13485 is an international standard that specifies the requirements for a quality management system (QMS) in the medical device industry. It outlines the framework and criteria that organizations need to meet to ensure the safety and effectiveness of their products.

Previous Versions

Before we delve into the current version, let's briefly touch upon the previous versions of EN ISO 13485. The first standard was published in 1996, followed by revisions in 2003 and 2012. Each subsequent version aimed to address emerging challenges and align with evolving regulatory frameworks.

The Current Version: EN ISO 13485:2016

The most recent version of EN ISO 13485 was published in 2016. This edition introduced several important updates and enhancements to the standard. One of the notable changes was the increased focus on risk management throughout the product lifecycle.

In addition to bolstering risk management practices, EN ISO 13485:2016 emphasized the importance of process validation, post-market surveillance, and supplier management. These requirements help ensure that medical device manufacturers consistently meet customer expectations while complying with regulatory obligations.

Benefits of Adopting EN ISO 13485:2016

Compliance with EN ISO 13485:2016 brings a range of benefits to organizations operating in the medical device industry. Firstly, it helps build consumer trust and confidence by demonstrating a commitment to quality and patient safety.

By adopting this standard, companies can establish robust processes, improve efficiency, and reduce the risk of errors or defects. A well-rounded QMS also enables organizations to identify potential issues early on and take proactive measures to mitigate them, leading to cost savings and enhanced customer satisfaction.


In conclusion, the current version of EN ISO 13485 is EN ISO 13485:2016. This standard plays a crucial role in ensuring that medical device manufacturers adhere to best practices and maintain high standards of quality and safety. By embracing EN ISO 13485:2016, organizations can not only enhance their reputation but also drive continual improvement throughout their operations.

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