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Understanding the Basics of ISO 13485 for Medical Device Quality Management Systems (QMS)

ISO 13485 for Medical Device Quality Management Systems is growing in popularity, with the number of certified facilities jumping 13% from 2015 to 2016.

But how is ISO 13485 different from ISO 9001 for Quality Management, and who should certify?

In this post, we’ll take a look at the basics of ISO 13485 to help you decide whether it’s worth pursuing this certification.

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