{"id":2106,"date":"2018-05-28T22:57:34","date_gmt":"2018-05-28T21:57:34","guid":{"rendered":"https:\/\/maatel.com\/?page_id=2106"},"modified":"2021-07-13T16:47:06","modified_gmt":"2021-07-13T15:47:06","slug":"medical-electronics-expertise","status":"publish","type":"page","link":"https:\/\/maatel.com\/staging\/en\/know-how\/medical-electronics-expertise\/","title":{"rendered":"Medical electronics expertise"},"content":{"rendered":"<h1>Our Medical Electronics Expertise<\/h1>\n<p><img decoding=\"async\" src=\"\/wp-content\/uploads\/deco-title-green.svg\" alt=\"\"><\/p>\n<h1>Over 30 years\u2019 experience with medical devices<\/h1>\n<h3>\n<p>Specialized design in Electronic Medical Devices<\/p>\n<\/h3>\n<div>\n<p>MAATEL has NF EN ISO 13485 (V.2012) certification and a wealth of expertise in product compliance for European certification and accreditation by the FDA (Foods and Drugs Administration), the public body responsible for the safety of drugs and medical devices in the United States.<\/p>\n<p>MAATEL\u2019s experience is built on the design and production of electronic medical devices for over 30 years.<\/p>\n<\/div>\n<div>\n<div>\n<table>\n<tbody>\n<tr>\n<td>MD<br \/>AIMD<br \/>IVDD<\/td>\n<td style=\"padding-left: 40px;\">Dir 93\/42\/EEC (class l, lla, llb, lll)<br \/>Dir 90\/385\/EEC<br \/>Dir 98\/79\/EC (class A, B, C, D)<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n<\/div>\n<p><img decoding=\"async\" src=\"\/wp-content\/uploads\/Logo-couleur.jpg\" alt=\"\"><\/p>\n<h3>\n<p>Our creations<\/p>\n<\/h3>\n<ul>\n<li>\n<p>        <img decoding=\"async\" src=\"\/wp-content\/uploads\/accompagnement-medical.jpg\" alt=\"\"><\/p>\n<h3>Automated medical assistance for treating prostate cancer<\/h3>\n<div>\n<ul>\n<li>Class I medical device<\/li>\n<li>Class C software<\/li>\n<li>Design of digital and analog circuit boards, motor controls, 6 axes Embedded Linux, real-time Cortex M7<\/li>\n<li>High-speed USB and Ethernet connection<\/li>\n<li>Direct current (DC) driven motors, with torque<\/li>\n<li>Redundancy sensors<\/li>\n<\/ul>\n<\/div>\n<\/li>\n<li>\n<p>        <img decoding=\"async\" src=\"\/wp-content\/uploads\/Maatel-devellopement_carthera_biotherapie_cerebrale.jpg\" alt=\"\"><\/p>\n<h3>Cerebral biotherapy device<\/h3>\n<div>\n<ul>\n<li>Class III medical device<\/li>\n<li>Class C software<\/li>\n<li>ISO 13485 development<\/li>\n<li>Analog and digital electronic development Sinus amplifier 1.5Mhz 35 W. Embedded software development<\/li>\n<li>Customer approval phase Future developments: CE marking and clinical trials<\/li>\n<li>Small volume production<\/li>\n<\/ul>\n<\/div>\n<\/li>\n<li>\n<p>        <img decoding=\"async\" src=\"\/wp-content\/uploads\/g916.png\" alt=\"\"><\/p>\n<h3>Dental implant device<\/h3>\n<div>\n<ul>\n<li>Class IIb medical device<\/li>\n<li>Class B software<\/li>\n<li>ISO 13485 development FDA<\/li>\n<li>Brushless direct current (DC) motor with torque and speed<\/li>\n<li>User interface<\/li>\n<li>Digital and power electronics<\/li>\n<li>Circuit board and embedded software, HMI and power-assisted design<\/li>\n<li>Circuit board production: 500 units per year<\/li>\n<\/ul>\n<\/div>\n<\/li>\n<li>\n<p>        <img decoding=\"async\" src=\"\/wp-content\/uploads\/pousse_seringue_maatel_electronique_.jpg\" alt=\"\"><\/p>\n<h3>Perfusion pump<\/h3>\n<div>\n<ul>\n<li>Class IIb medical device<\/li>\n<li>Class C software<\/li>\n<li>ISO 13485 and 21_CFR_part_820 development<\/li>\n<li>Stepper-motor controls Safety-sensor controls HMI Communication<\/li>\n<li>Design of circuit boards based on STM32 and embedded software \u2013 450 modules \u2013 290,000 lines<\/li>\n<li>Production exceeds 50,000 per year<\/li>\n<\/ul>\n<\/div>\n<\/li>\n<\/ul>\n<p><img decoding=\"async\" src=\"\/wp-content\/uploads\/deco-title-green.svg\" alt=\"\"><\/p>\n<h2>International standard monitoring<\/h2>\n<div>\n<p>MAATEL aims to grow their activity in compliance with European and international standards.<br \/>We are particularly attentive to our adherence with the latest regulatory requirements.<\/p>\n<p><span style=\"color: #00a297;\"><strong>At Maatel, we apply the following standards:<\/strong><\/span><\/p>\n<ul>\n<li>EN 60601-1 Standard and derivatives: general standards for basic security and essential performance for electronic devices.<\/li>\n<li>EN 62304 Standard: medical device software, software life cycle processes.<\/li>\n<li>21CFR820 FDA QUALITY SYSTEM REGULATION (QSR) Medical devices<\/li>\n<\/ul>\n<\/div>\n<p><img decoding=\"async\" src=\"\/wp-content\/uploads\/deco-title-green.svg\" alt=\"\"><\/p>\n<h2>Risk control for your medical device<\/h2>\n<h3>\n<p>Criticality Matrix<\/p>\n<\/h3>\n<div>\n<p><strong>For any medical device, containing risks is obligatory and stringent attention is required.<\/strong><\/p>\n<p>Risk analysis is conducted with you throughout your project: this first analysis allows for the identification of the criticality matrix. This matrix is fundamental to identifying critical points for design, and establishing the list of tests to conduct, as well as parameters to respect, either during prototype design, product industrialization or production.<\/p>\n<\/div>\n<p><img decoding=\"async\" src=\"\/wp-content\/uploads\/DSD_3478.jpg\" alt=\"\"><\/p>\n<div>\n<p><strong>These requirements are applied throughout the complete quality control system at each phase of the product life cycle.<\/strong><\/p>\n<p>Thanks to our experience in design and mass production of electronic medical devices, MAATEL is the best choice for analyzing the technical risk of your product with the application of stringent standards in monitoring.<\/p>\n<p>Maatel\u2019s expertise in risk analysis and management applies the requirements featured in the ISO 14971 standard for the \u201cApplication of risk management to medical devices\u201d.<\/p>\n<\/div>\n<p>\n    <a href=\"\/en\/know-how\/industrial-electronics-expertise\/#sensqualite\">Rigorous quality process<\/a>\n<\/p>\n<p><img decoding=\"async\" src=\"\/wp-content\/uploads\/quality_maatel.jpg\" alt=\"\"><\/p>\n<h3>\n<p>Version quality control<\/p>\n<\/h3>\n<div>\n<p><strong>Applying standards to many medical devices requires your product and prototypes to be versioned.<\/strong><br \/><strong>This involves a range of practices, processes and tools to guarantee traceability of any product evolution, and a record of the complete history and all versions.<\/strong><\/p>\n<p>Maatel uses two \u2018versioning\u2019 tools:<\/p>\n<ul>\n<li>GFORGE: collaboration management software for tracking product modifications and non-conformities, and associating them with a version.<\/li>\n<li>Subversion (abbreviation: svn): version management software<\/li>\n<\/ul>\n<p>Apart from compliance with medical standards, versioning tracks improvements for after-sales service of previous versions of your product, and to plan possible technical improvements.<\/p>\n<\/div>\n<p><img decoding=\"async\" src=\"\/wp-content\/uploads\/MAATEL_ESD_electronique.png\" alt=\"\"><\/p>\n<p><!--more--><br \/>\n<!-- {\"name\":\"\",\"type\":\"layout\",\"children\":[{\"name\":\"Page Headline\",\"type\":\"section\",\"props\":{\"style\":\"default\",\"width\":\"default\",\"vertical_align\":\"middle\",\"title_position\":\"top-left\",\"title_rotation\":\"left\",\"title_breakpoint\":\"xl\",\"image_position\":\"center-center\",\"image\":\"wp-content\\\/uploads\\\/deco-04-1-1-serene-iot-top.svg\",\"padding\":\"large\"},\"children\":[{\"name\":\"\",\"type\":\"row\",\"children\":[{\"name\":\"\",\"type\":\"column\",\"props\":{\"image_position\":\"center-center\",\"width_medium\":\"1-1\",\"media_overlay_gradient\":\"\"},\"children\":[{\"name\":\"\",\"type\":\"headline\",\"props\":{\"title_element\":\"h1\",\"content\":\"Our Medical Electronics Expertise\",\"title_color\":\"primary\",\"text_align\":\"center\",\"title_style\":\"heading-small\"}}]}]}]},{\"name\":\"\",\"type\":\"section\",\"props\":{\"style\":\"default\",\"width\":\"default\",\"vertical_align\":\"middle\",\"title_position\":\"top-left\",\"title_rotation\":\"left\",\"title_breakpoint\":\"xl\",\"image_position\":\"center-center\"},\"children\":[{\"name\":\"\",\"type\":\"row\",\"props\":{\"layout\":\"1-2,1-2\",\"vertical_align\":true},\"children\":[{\"name\":\"\",\"type\":\"column\",\"props\":{\"image_position\":\"center-center\",\"width_medium\":\"1-2\",\"media_overlay_gradient\":\"\"},\"children\":[{\"name\":\"\",\"type\":\"image\",\"props\":{\"margin\":\"default\",\"image\":\"wp-content\\\/uploads\\\/deco-title-green.svg\",\"margin_remove_bottom\":false,\"image_svg_color\":\"emphasis\"}},{\"name\":\"\",\"type\":\"headline\",\"props\":{\"title_element\":\"h1\",\"content\":\"Over 30 years\\u2019 experience with medical devices\",\"margin_remove_top\":true,\"title_style\":\"heading-small\"}},{\"name\":\"\",\"type\":\"headline\",\"props\":{\"title_element\":\"h3\",\"content\":\"\n\n<p>Specialized design in Electronic Medical Devices<\\\/p>\",\"title_color\":\"primary\",\"margin\":\"default\",\"margin_remove_bottom\":true}},{\"name\":\"\",\"type\":\"text\",\"props\":{\"margin\":\"default\",\"column_breakpoint\":\"m\",\"content\":\"\n\n<p>MAATEL has NF EN ISO 13485 (V.2012) certification and a wealth of expertise in product compliance for European certification and accreditation by the FDA (Foods and Drugs Administration), the public body responsible for the safety of drugs and medical devices in the United States.<\\\/p>\\n\n\n<p>MAATEL\\u2019s experience is built on the design and production of electronic medical devices for over 30 years.<\\\/p>\",\"margin_remove_top\":true}}]},{\"name\":\"\",\"type\":\"column\",\"props\":{\"image_position\":\"center-center\",\"width_medium\":\"1-2\",\"media_overlay_gradient\":\"\"},\"children\":[{\"name\":\"\",\"type\":\"panel\",\"props\":{\"link_text\":\"Read more\",\"title_element\":\"h3\",\"meta_style\":\"meta\",\"meta_align\":\"below-title\",\"image_align\":\"top\",\"image_grid_width\":\"1-2\",\"link_style\":\"default\",\"margin\":\"default\",\"content\":\"\n\n<table>\\n\n\n<tbody>\\n\n\n<tr>\\n\n\n<td>MD<br \\\/>AIMD<br \\\/>IVDD<\\\/td>\\n\n\n<td style=\\\"padding-left: 40px;\\\">Dir 93\\\/42\\\/EEC (class l, lla, llb, lll)<br \\\/>Dir 90\\\/385\\\/EEC<br \\\/>Dir 98\\\/79\\\/EC (class A, B, C, D)<\\\/td>\\n<\\\/tr>\\n<\\\/tbody>\\n<\\\/table>\",\"panel_style\":\"card-primary\",\"image_grid_breakpoint\":\"m\",\"icon_width\":80,\"title_hover_style\":\"reset\",\"title_align\":\"top\",\"title_grid_width\":\"1-2\",\"title_grid_breakpoint\":\"m\",\"meta_element\":\"div\",\"content_column_breakpoint\":\"m\",\"image_svg_color\":\"emphasis\"}},{\"name\":\"\",\"type\":\"image\",\"props\":{\"margin\":\"default\",\"image\":\"wp-content\\\/uploads\\\/Logo-couleur.jpg\",\"image_width\":\"250\",\"text_align\":\"center\",\"image_svg_color\":\"emphasis\"}}]}]}]},{\"name\":\"\",\"type\":\"section\",\"props\":{\"style\":\"default\",\"width\":\"default\",\"vertical_align\":\"middle\",\"title_position\":\"top-left\",\"title_rotation\":\"left\",\"title_breakpoint\":\"xl\",\"image_position\":\"center-center\",\"image\":\"wp-content\\\/uploads\\\/bg-realisations-medicales-2.svg\",\"image_size\":\"cover\"},\"children\":[{\"name\":\"\",\"type\":\"row\",\"props\":{\"layout\":\"large,expand,large\",\"width\":\"default\"},\"children\":[{\"name\":\"\",\"type\":\"column\",\"props\":{\"image_position\":\"center-center\",\"width_medium\":\"small\",\"media_overlay_gradient\":\"\"}},{\"name\":\"\",\"type\":\"column\",\"props\":{\"image_position\":\"center-center\",\"width_medium\":\"expand\",\"media_overlay_gradient\":\"\"},\"children\":[{\"name\":\"\",\"type\":\"headline\",\"props\":{\"title_element\":\"h3\",\"content\":\"\n\n<p>Our creations<\\\/p>\",\"title_color\":\"primary\",\"margin\":\"medium\",\"margin_remove_bottom\":false,\"text_align\":\"center\"}},{\"name\":\"\",\"type\":\"accordion\",\"props\":{\"show_image\":true,\"show_link\":true,\"collapsible\":true,\"image_align\":\"left\",\"image_grid_width\":\"1-2\",\"link_text\":\"Read more\",\"link_style\":\"default\",\"image_vertical_align\":true,\"image_grid_breakpoint\":\"m\",\"content_column_breakpoint\":\"m\",\"image_svg_color\":\"emphasis\"},\"children\":[{\"name\":\"\",\"type\":\"accordion_item\",\"props\":{\"content\":\"\n\n<ul>\\n\n\n<li>Class I medical device<\\\/li>\\n\n\n<li>Class C software<\\\/li>\\n\n\n<li>Design of digital and analog circuit boards, motor controls, 6 axes Embedded Linux, real-time Cortex M7<\\\/li>\\n\n\n<li>High-speed USB and Ethernet connection<\\\/li>\\n\n\n<li>Direct current (DC) driven motors, with torque<\\\/li>\\n\n\n<li>Redundancy sensors<\\\/li>\\n<\\\/ul>\",\"title\":\"Automated medical assistance for treating prostate cancer\",\"image\":\"wp-content\\\/uploads\\\/accompagnement-medical.jpg\"}},{\"name\":\"\",\"type\":\"accordion_item\",\"props\":{\"content\":\"\n\n<ul>\\n\n\n<li>Class III medical device<\\\/li>\\n\n\n<li>Class C software<\\\/li>\\n\n\n<li>ISO 13485 development<\\\/li>\\n\n\n<li>Analog and digital electronic development Sinus amplifier 1.5Mhz 35 W. Embedded software development<\\\/li>\\n\n\n<li>Customer approval phase Future developments: CE marking and clinical trials<\\\/li>\\n\n\n<li>Small volume production<\\\/li>\\n<\\\/ul>\",\"title\":\"Cerebral biotherapy device\",\"image\":\"wp-content\\\/uploads\\\/Maatel-devellopement_carthera_biotherapie_cerebrale.jpg\"}},{\"name\":\"\",\"type\":\"accordion_item\",\"props\":{\"content\":\"\n\n<ul>\\n\n\n<li>Class IIb medical device<\\\/li>\\n\n\n<li>Class B software<\\\/li>\\n\n\n<li>ISO 13485 development FDA<\\\/li>\\n\n\n<li>Brushless direct current (DC) motor with torque and speed<\\\/li>\\n\n\n<li>User interface<\\\/li>\\n\n\n<li>Digital and power electronics<\\\/li>\\n\n\n<li>Circuit board and embedded software, HMI and power-assisted design<\\\/li>\\n\n\n<li>Circuit board production: 500 units per year<\\\/li>\\n<\\\/ul>\",\"title\":\"Dental implant device\",\"image\":\"wp-content\\\/uploads\\\/g916.png\"}},{\"name\":\"\",\"type\":\"accordion_item\",\"props\":{\"content\":\"\n\n<ul>\\n\n\n<li>Class IIb medical device<\\\/li>\\n\n\n<li>Class C software<\\\/li>\\n\n\n<li>ISO 13485 and 21_CFR_part_820 development<\\\/li>\\n\n\n<li>Stepper-motor controls Safety-sensor controls HMI Communication<\\\/li>\\n\n\n<li>Design of circuit boards based on STM32 and embedded software \\u2013 450 modules \\u2013 290,000 lines<\\\/li>\\n\n\n<li>Production exceeds 50,000 per year<\\\/li>\\n<\\\/ul>\",\"title\":\"Perfusion pump\",\"image\":\"wp-content\\\/uploads\\\/pousse_seringue_maatel_electronique_.jpg\"}}]}]},{\"name\":\"\",\"type\":\"column\",\"props\":{\"image_position\":\"center-center\",\"width_medium\":\"small\",\"media_overlay_gradient\":\"\"}}]}]},{\"name\":\"\",\"type\":\"section\",\"props\":{\"style\":\"default\",\"width\":\"default\",\"vertical_align\":\"middle\",\"title_position\":\"top-left\",\"title_rotation\":\"left\",\"title_breakpoint\":\"xl\",\"image_position\":\"center-center\",\"image\":\"\"},\"children\":[{\"name\":\"\",\"type\":\"row\",\"children\":[{\"name\":\"\",\"type\":\"column\",\"props\":{\"image_position\":\"center-center\",\"width_medium\":\"1-1\",\"media_overlay_gradient\":\"\"},\"children\":[{\"name\":\"\",\"type\":\"image\",\"props\":{\"margin\":\"default\",\"image\":\"wp-content\\\/uploads\\\/deco-title-green.svg\",\"margin_remove_bottom\":false,\"image_svg_color\":\"emphasis\"}},{\"name\":\"\",\"type\":\"headline\",\"props\":{\"title_element\":\"h2\",\"content\":\"International standard monitoring\",\"margin_remove_top\":true,\"title_style\":\"h1\"}},{\"name\":\"\",\"type\":\"text\",\"props\":{\"margin\":\"default\",\"column_breakpoint\":\"m\",\"content\":\"\n\n<p>MAATEL aims to grow their activity in compliance with European and international standards.<br \\\/>We are particularly attentive to our adherence with the latest regulatory requirements.<\\\/p>\\n\n\n<p><span style=\\\"color: #00a297;\\\"><strong>At Maatel, we apply the following standards:<\\\/strong><\\\/span><\\\/p>\\n\n\n<ul>\\n\n\n<li>EN 60601-1 Standard and derivatives: general standards for basic security and essential performance for electronic devices.<\\\/li>\\n\n\n<li>EN 62304 Standard: medical device software, software life cycle processes.<\\\/li>\\n\n\n<li>21CFR820 FDA QUALITY SYSTEM REGULATION (QSR) Medical devices<\\\/li>\\n<\\\/ul>\"}}]}]},{\"name\":\"\",\"type\":\"row\",\"props\":{\"layout\":\"1-2,1-2\",\"vertical_align\":true,\"margin\":\"large\"},\"children\":[{\"name\":\"\",\"type\":\"column\",\"props\":{\"image_position\":\"center-center\",\"width_medium\":\"1-2\",\"media_overlay_gradient\":\"\"},\"children\":[{\"name\":\"\",\"type\":\"image\",\"props\":{\"margin\":\"default\",\"image\":\"wp-content\\\/uploads\\\/deco-title-green.svg\",\"margin_remove_bottom\":false,\"image_svg_color\":\"emphasis\"}},{\"name\":\"\",\"type\":\"headline\",\"props\":{\"title_element\":\"h2\",\"content\":\"Risk control for your medical device\",\"margin_remove_top\":true,\"title_style\":\"h1\"}},{\"name\":\"\",\"type\":\"headline\",\"props\":{\"title_element\":\"h3\",\"content\":\"\n\n<p>Criticality Matrix<\\\/p>\",\"title_color\":\"primary\",\"margin_remove_bottom\":true}},{\"name\":\"\",\"type\":\"text\",\"props\":{\"margin\":\"default\",\"column_breakpoint\":\"m\",\"content\":\"\n\n<p><strong>For any medical device, containing risks is obligatory and stringent attention is required.<\\\/strong><\\\/p>\\n\n\n<p>Risk analysis is conducted with you throughout your project: this first analysis allows for the identification of the criticality matrix. This matrix is fundamental to identifying critical points for design, and establishing the list of tests to conduct, as well as parameters to respect, either during prototype design, product industrialization or production.<\\\/p>\",\"margin_remove_top\":true}}]},{\"name\":\"\",\"type\":\"column\",\"props\":{\"image_position\":\"center-center\",\"width_medium\":\"1-2\",\"media_overlay_gradient\":\"\"},\"children\":[{\"name\":\"\",\"type\":\"image\",\"props\":{\"margin\":\"default\",\"image\":\"wp-content\\\/uploads\\\/DSD_3478.jpg\",\"image_box_shadow_bottom\":true,\"image_border\":\"rounded\",\"image_box_decoration\":\"shadow\",\"image_svg_color\":\"emphasis\"}}]}]},{\"name\":\"\",\"type\":\"row\",\"props\":{\"layout\":\"1-2,1-2\",\"vertical_align\":true,\"margin\":\"large\"},\"children\":[{\"name\":\"\",\"type\":\"column\",\"props\":{\"image_position\":\"center-center\",\"width_medium\":\"1-2\",\"media_overlay_gradient\":\"\"},\"children\":[{\"name\":\"\",\"type\":\"text\",\"props\":{\"margin\":\"default\",\"column_breakpoint\":\"m\",\"content\":\"\n\n<p><strong>These requirements are applied throughout the complete quality control system at each phase of the product life cycle.<\\\/strong><\\\/p>\\n\n\n<p>Thanks to our experience in design and mass production of electronic medical devices, MAATEL is the best choice for analyzing the technical risk of your product with the application of stringent standards in monitoring.<\\\/p>\\n\n\n<p>Maatel\\u2019s expertise in risk analysis and management applies the requirements featured in the ISO 14971 standard for the \\u201cApplication of risk management to medical devices\\u201d.<\\\/p>\"}},{\"name\":\"\",\"type\":\"button\",\"props\":{\"margin\":\"default\",\"grid_column_gap\":\"small\",\"grid_row_gap\":\"small\"},\"children\":[{\"name\":\"\",\"type\":\"button_item\",\"props\":{\"button_style\":\"default\",\"icon_align\":\"left\",\"link\":\"\\\/en\\\/know-how\\\/industrial-electronics-expertise\\\/#sensqualite\",\"content\":\"Rigorous quality process\",\"link_title\":\"Our quality process\"}}]}]},{\"name\":\"\",\"type\":\"column\",\"props\":{\"image_position\":\"center-center\",\"width_medium\":\"1-2\",\"order_first\":\"m\",\"media_overlay_gradient\":\"\"},\"children\":[{\"name\":\"\",\"type\":\"image\",\"props\":{\"margin\":\"default\",\"image\":\"wp-content\\\/uploads\\\/quality_maatel.jpg\",\"image_border\":\"rounded\",\"image_box_shadow_bottom\":true,\"image_box_decoration\":\"shadow\",\"image_svg_color\":\"emphasis\"}}]}]},{\"name\":\"\",\"type\":\"row\",\"props\":{\"vertical_align\":true,\"margin\":\"xlarge\"},\"children\":[{\"name\":\"\",\"type\":\"column\",\"props\":{\"image_position\":\"center-center\",\"width_medium\":\"1-1\",\"media_overlay_gradient\":\"\"},\"children\":[{\"name\":\"\",\"type\":\"headline\",\"props\":{\"title_element\":\"h3\",\"content\":\"\n\n<p>Version quality control<\\\/p>\",\"title_color\":\"primary\",\"margin_remove_bottom\":true}},{\"name\":\"\",\"type\":\"text\",\"props\":{\"margin\":\"default\",\"column_breakpoint\":\"m\",\"content\":\"\n\n<p><strong>Applying standards to many medical devices requires your product and prototypes to be versioned.<\\\/strong><br \\\/><strong>This involves a range of practices, processes and tools to guarantee traceability of any product evolution, and a record of the complete history and all versions.<\\\/strong><\\\/p>\\n\n\n<p>Maatel uses two \\u2018versioning\\u2019 tools:<\\\/p>\\n\n\n<ul>\\n\n\n<li>GFORGE: collaboration management software for tracking product modifications and non-conformities, and associating them with a version.<\\\/li>\\n\n\n<li>Subversion (abbreviation: svn): version management software<\\\/li>\\n<\\\/ul>\\n\n\n<p>Apart from compliance with medical standards, versioning tracks improvements for after-sales service of previous versions of your product, and to plan possible technical improvements.<\\\/p>\",\"margin_remove_top\":true}},{\"name\":\"\",\"type\":\"image\",\"props\":{\"margin\":\"large\",\"text_align\":\"center\",\"image\":\"wp-content\\\/uploads\\\/MAATEL_ESD_electronique.png\",\"image_box_shadow_bottom\":true,\"image_border\":\"rounded\",\"image_box_decoration\":\"shadow\",\"image_svg_color\":\"emphasis\"}}]}]}]}],\"version\":\"2.4.17\"} --><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Our Medical Electronics Expertise Over 30 years\u2019 experience with medical devices Specialized design in Electronic Medical Devices MAATEL has NF EN ISO 13485 (V.2012) certification and a wealth of expertise in product compliance for European certification and accreditation by the FDA (Foods and Drugs Administration), the public body responsible for the safety of drugs and [&hellip;]<\/p>\n","protected":false},"author":5,"featured_media":0,"parent":2098,"menu_order":1,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"_seopress_robots_primary_cat":"0","_seopress_titles_title":"","_seopress_titles_desc":"","_seopress_robots_index":"","footnotes":"","_members_access_role":[],"_members_access_error":""},"class_list":["post-2106","page","type-page","status-publish","hentry"],"acf":[],"_links":{"self":[{"href":"https:\/\/maatel.com\/staging\/wp-json\/wp\/v2\/pages\/2106","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/maatel.com\/staging\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/maatel.com\/staging\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/maatel.com\/staging\/wp-json\/wp\/v2\/users\/5"}],"replies":[{"embeddable":true,"href":"https:\/\/maatel.com\/staging\/wp-json\/wp\/v2\/comments?post=2106"}],"version-history":[{"count":0,"href":"https:\/\/maatel.com\/staging\/wp-json\/wp\/v2\/pages\/2106\/revisions"}],"up":[{"embeddable":true,"href":"https:\/\/maatel.com\/staging\/wp-json\/wp\/v2\/pages\/2098"}],"wp:attachment":[{"href":"https:\/\/maatel.com\/staging\/wp-json\/wp\/v2\/media?parent=2106"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}