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With the EU Medical Device Directive (MDD) and In Vitro Diagnostic Device Directive (IVDD) undergoing revision and ISO 13485:2016 (Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes) having been published on March 1, 2016 for the first time since 2003, medical device manufacturers everywhere are having to cope with the industry’s most significant regulatory overhaul in years.

How do these changes impact your organization and what does it all mean for your quality management system? Where do you start in determining how to implement the relevant changes to meet the requirements of the new ISO 13485:2016 standard?

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