![]() Recently, Monsenso has upgraded its QMS to the latest version of the standard EN ISO 13485 to the new revision: DS/EN ISO 13485:2016. ![]() Monsenso mHealth solution first achieved DS/EN ISO 13485:2012 in July 11, 2016.ĭeveloping our QMS is a continuous process. ISO 13485 is an internationally agreed standard by ISO (the International Organization for Standardization) that sets out the requirements for a Quality Management System (QMS) specific to the medical devices industry.
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