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Thursday 22 January 2015

Getting Ready for ISO 13485:201X (Part 1)

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The quality management standard for med devices is changing.
by Lisa Weeks, Marketing Communications

As most of you know, ISO 13485–Quality Management Systems—Requirements for Regulatory Purposes is being revised. ISO 13485:201X, as the final revision is being referred to, is expected to be available in late 2015 or early 2016. Understandably, this is causing anxiety for medical device manufacturers, many of whom are still struggling to conform to the current version of the standard. With this in mind, let’s review the basics of the ISO: 13485. In future posts, we’ll examine why the standard is being updated, and the most significant changes you can expect to see. 

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