ISO 13485 version 2016 medical certification

Qualimatest has recertified its entire organization according to the new standards ISO 9001: 2015 and ISO 13485: 2016

After successfully passing the ISO 13485: 2012 certification in 2014, Qualimatest has been successfully recertified according to the 2016 version of ISO 13485.

ISO 13485 (Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes) specifies the requirements of quality management systems (QMS) for the medical device industry, in particular:


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Michele Iarocci
Quality and Validations Manager

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