{"id":18491,"date":"2020-05-14T09:06:50","date_gmt":"2020-05-14T09:06:50","guid":{"rendered":"https:\/\/mjn.cat\/?p=18491"},"modified":"2021-08-30T13:51:44","modified_gmt":"2021-08-30T11:51:44","slug":"mjn-obtains-the-ce-medical-device-certification-for-its-epilepsy-aid-solution","status":"publish","type":"post","link":"https:\/\/mjn.cat\/en\/corporation\/mjn-obtains-the-ce-medical-device-certification-for-its-epilepsy-aid-solution\/","title":{"rendered":"mjn-neuro obtains the CE medical device certification for its epilepsy aid solution"},"content":{"rendered":"[vc_row type=&#8221;in_container&#8221; full_screen_row_position=&#8221;middle&#8221; column_margin=&#8221;default&#8221; column_direction=&#8221;default&#8221; column_direction_tablet=&#8221;default&#8221; column_direction_phone=&#8221;default&#8221; scene_position=&#8221;center&#8221; text_color=&#8221;dark&#8221; text_align=&#8221;left&#8221; row_border_radius=&#8221;none&#8221; row_border_radius_applies=&#8221;bg&#8221; overlay_strength=&#8221;0.3&#8243; gradient_direction=&#8221;left_to_right&#8221; shape_divider_position=&#8221;bottom&#8221; bg_image_animation=&#8221;none&#8221;][vc_column column_padding=&#8221;padding-5-percent&#8221; column_padding_tablet=&#8221;inherit&#8221; column_padding_phone=&#8221;inherit&#8221; column_padding_position=&#8221;left-right&#8221; background_color_opacity=&#8221;1&#8243; background_hover_color_opacity=&#8221;1&#8243; column_shadow=&#8221;none&#8221; column_border_radius=&#8221;none&#8221; column_link_target=&#8221;_self&#8221; el_class=&#8221;justify&#8221; gradient_direction=&#8221;left_to_right&#8221; overlay_strength=&#8221;0.3&#8243; width=&#8221;1\/1&#8243; tablet_width_inherit=&#8221;default&#8221; tablet_text_alignment=&#8221;default&#8221; phone_text_alignment=&#8221;default&#8221; column_border_width=&#8221;none&#8221; column_border_style=&#8221;solid&#8221; bg_image_animation=&#8221;none&#8221;][vc_row_inner equal_height=&#8221;yes&#8221; content_placement=&#8221;middle&#8221; column_margin=&#8221;default&#8221; column_direction=&#8221;default&#8221; column_direction_tablet=&#8221;default&#8221; column_direction_phone=&#8221;default&#8221; text_align=&#8221;left&#8221;][vc_column_inner column_padding=&#8221;padding-5-percent&#8221; column_padding_tablet=&#8221;inherit&#8221; column_padding_phone=&#8221;inherit&#8221; column_padding_position=&#8221;left-right&#8221; background_color_opacity=&#8221;1&#8243; background_hover_color_opacity=&#8221;1&#8243; column_shadow=&#8221;none&#8221; column_border_radius=&#8221;none&#8221; column_link_target=&#8221;_self&#8221; gradient_direction=&#8221;left_to_right&#8221; overlay_strength=&#8221;0.3&#8243; width=&#8221;1\/1&#8243; tablet_width_inherit=&#8221;default&#8221; column_border_width=&#8221;none&#8221; column_border_style=&#8221;solid&#8221; bg_image_animation=&#8221;none&#8221;][vc_column_text]<span style=\"font-weight: 400;\"> The <strong>mjn-neuro<\/strong> project was born with two main objectives. The first is to develop a technological solution to help people with epilepsy improve their quality of life. The second, to work towards reducing the stigma that epilepsy still carries in society. <\/span><\/p>\n<p><span style=\"font-weight: 400;\"> Today we are going to talk about our first objective and the important milestone we have just achieved. <\/span><\/p>\n<p><span style=\"font-weight: 400;\"> When we started to develop our product, more than 8 years ago, we always knew that the design, manufacturing, safety tests, etc. had to meet a high level of quality. \u00a0For that reason, we defined that it needed to be a medical device and that it needed to accomplish all the existing regulations for medical devices. <\/span>[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][vc_row_inner equal_height=&#8221;yes&#8221; content_placement=&#8221;middle&#8221; column_margin=&#8221;default&#8221; column_direction=&#8221;default&#8221; column_direction_tablet=&#8221;default&#8221; column_direction_phone=&#8221;default&#8221; text_align=&#8221;left&#8221;][vc_column_inner column_padding=&#8221;padding-5-percent&#8221; column_padding_tablet=&#8221;inherit&#8221; column_padding_phone=&#8221;inherit&#8221; column_padding_position=&#8221;left-right&#8221; background_color_opacity=&#8221;1&#8243; background_hover_color_opacity=&#8221;1&#8243; column_shadow=&#8221;none&#8221; column_border_radius=&#8221;none&#8221; column_link_target=&#8221;_self&#8221; gradient_direction=&#8221;left_to_right&#8221; overlay_strength=&#8221;0.3&#8243; width=&#8221;5\/6&#8243; tablet_width_inherit=&#8221;default&#8221; column_border_width=&#8221;none&#8221; column_border_style=&#8221;solid&#8221; bg_image_animation=&#8221;none&#8221;][vc_column_text]<span style=\"font-weight: 400;\"> In Spain, the certificates required for a medical device to meet current regulations are three: <\/span><\/p>\n<ul>\n<li><span style=\"font-weight: 400;\">The ISO 13485:2016 certificate. This international standard specifies that <strong>mjn-neuro<\/strong> meets the requirements for providing medical products and services. <\/span><\/li>\n<li><span style=\"font-weight: 400;\"> The manufacturer&#8217;s license from the Spanish Agency for Medicines, AEMPS. This national standard authorizes <strong>mjn-neuro<\/strong> as a manufacturer of medical devices. <\/span><\/li>\n<li><span style=\"font-weight: 400;\"> Medical device CE certificate. This European standard indicates that the solution developed by <strong>mjn-neuro<\/strong> to evaluate the risk of epilepsy seizures is a medical device that complies with directive 93\/42\/EEC. <\/span><\/li>\n<\/ul>\n[\/vc_column_text][\/vc_column_inner][vc_column_inner column_padding=&#8221;no-extra-padding&#8221; column_padding_tablet=&#8221;inherit&#8221; column_padding_phone=&#8221;inherit&#8221; column_padding_position=&#8221;all&#8221; background_color_opacity=&#8221;1&#8243; background_hover_color_opacity=&#8221;1&#8243; column_shadow=&#8221;none&#8221; column_border_radius=&#8221;none&#8221; column_link_target=&#8221;_self&#8221; gradient_direction=&#8221;left_to_right&#8221; overlay_strength=&#8221;0.3&#8243; width=&#8221;1\/6&#8243; tablet_width_inherit=&#8221;default&#8221; column_border_width=&#8221;none&#8221; column_border_style=&#8221;solid&#8221; bg_image_animation=&#8221;none&#8221; offset=&#8221;vc_hidden-sm vc_hidden-xs&#8221;][split_line_heading animation_type=&#8221;default&#8221;]\n<h4>Obtaining the CE certificate is one of the most important milestones that our project has achieved<\/h4>\n[\/split_line_heading][\/vc_column_inner][\/vc_row_inner][vc_row_inner equal_height=&#8221;yes&#8221; content_placement=&#8221;middle&#8221; column_margin=&#8221;default&#8221; column_direction=&#8221;default&#8221; column_direction_tablet=&#8221;default&#8221; column_direction_phone=&#8221;default&#8221; text_align=&#8221;left&#8221;][vc_column_inner column_padding=&#8221;padding-5-percent&#8221; column_padding_tablet=&#8221;inherit&#8221; column_padding_phone=&#8221;inherit&#8221; column_padding_position=&#8221;left-right&#8221; background_color_opacity=&#8221;1&#8243; background_hover_color_opacity=&#8221;1&#8243; column_shadow=&#8221;none&#8221; column_border_radius=&#8221;none&#8221; column_link_target=&#8221;_self&#8221; gradient_direction=&#8221;left_to_right&#8221; overlay_strength=&#8221;0.3&#8243; width=&#8221;1\/1&#8243; tablet_width_inherit=&#8221;default&#8221; column_border_width=&#8221;none&#8221; column_border_style=&#8221;solid&#8221; bg_image_animation=&#8221;none&#8221;][vc_column_text]<span style=\"font-weight: 400;\"> Since 2019 we possess the ISO certificate and the license from the AEMPS. But obtaining the CE has been a much more laborious process for us as it has put to test from the beginning of the development of our solution, how we have designed it, how we have manufactured it, how we have tested it, that the use is safe for people, its operation and a very long etcetera. <\/span>[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][vc_row_inner equal_height=&#8221;yes&#8221; content_placement=&#8221;middle&#8221; column_margin=&#8221;default&#8221; column_direction=&#8221;default&#8221; column_direction_tablet=&#8221;default&#8221; column_direction_phone=&#8221;default&#8221; text_align=&#8221;left&#8221;][vc_column_inner column_padding=&#8221;padding-5-percent&#8221; column_padding_tablet=&#8221;inherit&#8221; column_padding_phone=&#8221;inherit&#8221; column_padding_position=&#8221;left-right&#8221; background_color_opacity=&#8221;1&#8243; background_hover_color_opacity=&#8221;1&#8243; column_shadow=&#8221;none&#8221; column_border_radius=&#8221;none&#8221; column_link_target=&#8221;_self&#8221; gradient_direction=&#8221;left_to_right&#8221; overlay_strength=&#8221;0.3&#8243; width=&#8221;1\/3&#8243; tablet_width_inherit=&#8221;default&#8221; column_border_width=&#8221;none&#8221; column_border_style=&#8221;solid&#8221; bg_image_animation=&#8221;none&#8221;][image_with_animation image_url=&#8221;18264&#8243; animation=&#8221;Fade In&#8221; hover_animation=&#8221;none&#8221; alignment=&#8221;center&#8221; border_radius=&#8221;none&#8221; box_shadow=&#8221;none&#8221; image_loading=&#8221;default&#8221; max_width=&#8221;100%&#8221; max_width_mobile=&#8221;default&#8221;][\/vc_column_inner][vc_column_inner column_padding=&#8221;padding-5-percent&#8221; column_padding_tablet=&#8221;inherit&#8221; column_padding_phone=&#8221;inherit&#8221; column_padding_position=&#8221;left-right&#8221; background_color_opacity=&#8221;1&#8243; background_hover_color_opacity=&#8221;1&#8243; column_shadow=&#8221;none&#8221; column_border_radius=&#8221;none&#8221; column_link_target=&#8221;_self&#8221; gradient_direction=&#8221;left_to_right&#8221; overlay_strength=&#8221;0.3&#8243; width=&#8221;2\/3&#8243; tablet_width_inherit=&#8221;default&#8221; column_border_width=&#8221;none&#8221; column_border_style=&#8221;solid&#8221; bg_image_animation=&#8221;none&#8221;][vc_column_text]<span style=\"font-weight: 400;\"> The entire <strong>mjn-neuro<\/strong> team has worked very hard to obtain the CE. Especially David Bl\u00e1nquez (CEO and technical manager of <strong>mjn-neuro<\/strong>), Xavier Raurich (operations manager), and Fernando Atienza (quality manager).<\/span><\/p>\n<p><span style=\"font-weight: 400;\"> Therefore we are very happy to inform you that since April 30th our epilepsy support solution has the CE certificate as a medical device. <\/span>[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][vc_row_inner equal_height=&#8221;yes&#8221; content_placement=&#8221;middle&#8221; column_margin=&#8221;default&#8221; column_direction=&#8221;default&#8221; column_direction_tablet=&#8221;default&#8221; column_direction_phone=&#8221;default&#8221; text_align=&#8221;left&#8221;][vc_column_inner column_padding=&#8221;padding-5-percent&#8221; column_padding_tablet=&#8221;inherit&#8221; column_padding_phone=&#8221;inherit&#8221; column_padding_position=&#8221;left-right&#8221; background_color_opacity=&#8221;1&#8243; background_hover_color_opacity=&#8221;1&#8243; column_shadow=&#8221;none&#8221; column_border_radius=&#8221;none&#8221; column_link_target=&#8221;_self&#8221; gradient_direction=&#8221;left_to_right&#8221; overlay_strength=&#8221;0.3&#8243; width=&#8221;1\/1&#8243; tablet_width_inherit=&#8221;default&#8221; column_border_width=&#8221;none&#8221; column_border_style=&#8221;solid&#8221; bg_image_animation=&#8221;none&#8221;][vc_column_text]<span style=\"font-weight: 400;\"> It has been a long and complex process since the requirements by the certifying organization are extremely strict, and the hours dedicated by the team members have been endless. In our case, the notified body that has evaluated us has been the prestigious international company BSI. <\/span><\/p>\n<p><span style=\"font-weight: 400;\"> Obtaining the CE certificate is one of the most important milestones that our project has achieved and opens the door for us to fulfill our main objective: That our solution becomes a reality to help so many people with refractory epilepsy in Spain and around the world. <\/span>[\/vc_column_text][image_with_animation image_url=&#8221;18510&#8243; animation=&#8221;Fade In&#8221; hover_animation=&#8221;none&#8221; alignment=&#8221;center&#8221; border_radius=&#8221;none&#8221; box_shadow=&#8221;none&#8221; image_loading=&#8221;default&#8221; max_width=&#8221;100%&#8221; max_width_mobile=&#8221;default&#8221;][\/vc_column_inner][\/vc_row_inner][vc_row_inner equal_height=&#8221;yes&#8221; content_placement=&#8221;middle&#8221; column_margin=&#8221;default&#8221; column_direction=&#8221;default&#8221; column_direction_tablet=&#8221;default&#8221; column_direction_phone=&#8221;default&#8221; text_align=&#8221;left&#8221;][vc_column_inner column_padding=&#8221;padding-5-percent&#8221; column_padding_tablet=&#8221;inherit&#8221; column_padding_phone=&#8221;inherit&#8221; column_padding_position=&#8221;left-right&#8221; background_color_opacity=&#8221;1&#8243; background_hover_color_opacity=&#8221;1&#8243; column_shadow=&#8221;none&#8221; column_border_radius=&#8221;none&#8221; column_link_target=&#8221;_self&#8221; gradient_direction=&#8221;left_to_right&#8221; overlay_strength=&#8221;0.3&#8243; width=&#8221;1\/1&#8243; tablet_width_inherit=&#8221;default&#8221; column_border_width=&#8221;none&#8221; column_border_style=&#8221;solid&#8221; bg_image_animation=&#8221;none&#8221;]<div class=\"sharing-default-minimal\"><div class=\"nectar-social default\" data-position=\"left\" data-color-override=\"override\"><div class=\"nectar-social-inner\"><a href=\"#\" class=\"nectar-love\" id=\"nectar-love-18491\" title=\"Love this\"> <i class=\"icon-salient-heart-2\"><\/i><span class=\"love-text\">Love<\/span><span class=\"total_loves\"><span class=\"nectar-love-count\">13<\/span><\/span><\/a><a class='facebook-share nectar-sharing' href='#' title='Share this'>  <i class='fa fa-facebook'><\/i> <span class='social-text'>Share<\/span> <\/a><a class='twitter-share nectar-sharing' href='#' title='Share this'> <i class='fa icon-salient-x-twitter'><\/i> <span class='social-text'>Share<\/span> <\/a><a class='linkedin-share nectar-sharing' href='#' title='Share this'> <i class='fa fa-linkedin'><\/i> <span class='social-text'>Share<\/span> <\/a><a class='pinterest-share nectar-sharing' href='#' title='Pin this'> <i class='fa fa-pinterest'><\/i> <span class='social-text'>Pin<\/span> <\/a><\/div><\/div><\/div>[\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row]\n","protected":false},"excerpt":{"rendered":"<p>[vc_row type=&#8221;in_container&#8221; full_screen_row_position=&#8221;middle&#8221; column_margin=&#8221;default&#8221; column_direction=&#8221;default&#8221; column_direction_tablet=&#8221;default&#8221; column_direction_phone=&#8221;default&#8221; scene_position=&#8221;center&#8221; text_color=&#8221;dark&#8221; text_align=&#8221;left&#8221; row_border_radius=&#8221;none&#8221; row_border_radius_applies=&#8221;bg&#8221; overlay_strength=&#8221;0.3&#8243; gradient_direction=&#8221;left_to_right&#8221; shape_divider_position=&#8221;bottom&#8221; bg_image_animation=&#8221;none&#8221;][vc_column column_padding=&#8221;padding-5-percent&#8221; column_padding_tablet=&#8221;inherit&#8221; column_padding_phone=&#8221;inherit&#8221; column_padding_position=&#8221;left-right&#8221;&#8230;<\/p>\n","protected":false},"author":1,"featured_media":18516,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[91],"tags":[],"class_list":["post-18491","post","type-post","status-publish","format-standard","has-post-thumbnail","category-corporation"],"aioseo_notices":[],"aioseo_head":"\n\t\t<!-- All in One SEO 5.0.5 - aioseo.com -->\n\t<meta name=\"description\" content=\"The mjn-neuro project was born with two main objectives. 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