Medical Devices – ISO 13485

ISO 13485:2016 – Medical Devices – The Latest Revision

February 12th, 2016|Medical Devices - ISO 13485|

ISO 13485:2016 - Medical Devices  Quality Management Systems - Requirements for Regulatory Purposes The international Medical Devices Quality Management Systems (QMS) ISO 13485 standard was revised and published in March 2016, giving us ISO 13485:2016. Why update the standard? [...]

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ISO 13485 : 2015 – the next revision

August 1st, 2014|Medical Devices - ISO 13485|

Voting has now closed on the next revision to ISO 13485 "Medical devices — Quality management systems — Requirements for regulatory purposes". All comments received by the ISO/TC 210 working group (the ISO group that is revising the standard), the comments will now be reviewed [...]

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