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ISO 13485 Medical Device Quality System Standard and Other Regulatory Conundrums - Featured Image

ISO 13485 Medical Device Quality System Standard and Other Regulatory Conundrums

By Edwin Bills, ASQ Fellow, RAC on April 1, 2019
The 2003 edition of ISO 13485 has now been withdrawn and fully replaced by the 2016 edition.[i]  As ...
Medical Device QMS Changes: How to Manage Changes Regarding EU MDR, IVDR & ISO 13485:2016 - Featured Image

Medical Device QMS Changes: How to Manage Changes Regarding EU MDR, IVDR & ISO 13485:2016

By Rod Beuzeval on January 30, 2018
One thing that seems to be constant in the global medical device industry is change.
EU MDR and IVDR Are Live – Here Are Some Important Items You Should Know! - Featured Image

EU MDR and IVDR Are Live – Here Are Some Important Items You Should Know!

By Dr. Gert W. Bos on May 16, 2017
After almost 10 years of careful deliberations, the new EU regulations on medical devices finally ha...

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