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[/fusion_title][/fusion_builder_column][fusion_builder_column type=”1_2″ layout=”1_2″ spacing=”” center_content=”no” link=”” target=”_self” min_height=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” background_color=”” background_image=”” background_position=”left top” undefined=”” background_repeat=”no-repeat” hover_type=”none” border_size=”0″ border_color=”#dbdbdb” border_style=”solid” border_position=”all” padding_top=”10″ padding_right=”30″ padding_bottom=”10″ padding_left=”30″ margin_top=”5″ margin_bottom=”5″ animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” last=”no”][fusion_text]05.12.2017
[/fusion_text][fusion_text]The new edition of the ISO 13485 standard was published on March 1 2016.
ISO 13485 defines the requirements for a quality management system designed to demonstrate an organization’s ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
The new ISO 13485:2016 focuses on how companies should manage risk-based decisions related to purchasing, design, development, manufacturing, production control activities and other aspects of the quality management system.
WeMed is proud to report that as a first step, we are updating the Quality Management System (QMS) to the new ISO 13485:2016.
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