{"id":82465,"date":"2024-05-02T22:23:00","date_gmt":"2024-05-03T04:23:00","guid":{"rendered":"https:\/\/pxsglobal.com\/?page_id=82465"},"modified":"2025-06-09T10:51:31","modified_gmt":"2025-06-09T16:51:31","slug":"cmda","status":"publish","type":"page","link":"https:\/\/pxsglobal.com\/en\/cmda\/","title":{"rendered":"CMDA"},"content":{"rendered":"<div data-elementor-type=\"wp-page\" data-elementor-id=\"82465\" class=\"elementor elementor-82465\" data-elementor-post-type=\"page\">\n\t\t\t\t\t\t<section data-parallax-section-settings=\"{&quot;parallax_ratio&quot;:1.4,&quot;parallax&quot;:&quot;parallax&quot;}\" class=\"elementor-section elementor-top-section elementor-element elementor-element-c553f6f elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"c553f6f\" data-element_type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t\t<div class=\"elementor-background-overlay\"><\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"full-screen elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-e01ce4b\" data-fullscreen-column-settings=\"{&quot;fullscreen&quot;:&quot;yes&quot;}\" data-id=\"e01ce4b\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-8a324e9 elementor-widget elementor-widget-slider_revolution\" data-id=\"8a324e9\" data-element_type=\"widget\" data-widget_type=\"slider_revolution.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\n\t\t<div class=\"wp-block-themepunch-revslider\">\n\t\t\t<!-- START CMDA REVOLUTION SLIDER 6.6.20 --><p class=\"rs-p-wp-fix\"><\/p>\n\t\t\t<rs-module-wrap id=\"rev_slider_96_1_wrapper\" data-source=\"gallery\" style=\"visibility:hidden;background:transparent;padding:0;\">\n\t\t\t\t<rs-module id=\"rev_slider_96_1\" class=\"rs-respect-topbar\" style=\"\" data-version=\"6.6.20\">\n\t\t\t\t\t<rs-slides style=\"overflow: hidden; position: absolute;\">\n\t\t\t\t\t\t<rs-slide style=\"position: absolute;\" data-key=\"rs-141\" data-title=\"Slide\" data-anim=\"eng:transitionPack;d:20;e:tpbasic;ms:1500ms;\" data-in=\"o:1;\" data-out=\"a:false;\">\n\t\t\t\t\t\t\t<img decoding=\"async\" src=\"\/\/pxsglobal.com\/wp-content\/plugins\/revslider\/public\/assets\/assets\/dummy.png\" alt=\"Slide\" title=\"CMDA\" class=\"rev-slidebg tp-rs-img rs-lazyload\" data-lazyload=\"\/\/pxsglobal.com\/wp-content\/plugins\/revslider\/public\/assets\/assets\/transparent.png\" data-bg=\"c:linear-gradient(160deg, rgba(35,21,87,1) 0%, rgba(68,16,122,1) 29%, rgba(255,19,97,1) 67%, rgba(255,248,0,1) 100%);\" data-parallax=\"off\" data-no-retina>\n<!--\t\t\t\t\t\t--><rs-zone id=\"rrzb_141\" class=\"rev_row_zone_bottom\" style=\"z-index: 4;\"><!--\n\n\t\t\t\t\t\t\t\t--><rs-row\n\t\t\t\t\t\t\t\t\tid=\"slider-96-slide-141-layer-4\" \n\t\t\t\t\t\t\t\t\tdata-type=\"row\"\n\t\t\t\t\t\t\t\t\tdata-xy=\"xo:50px;yo:50px;\"\n\t\t\t\t\t\t\t\t\tdata-cbreak=\"3\"\n\t\t\t\t\t\t\t\t\tdata-rsp_bd=\"off\"\n\t\t\t\t\t\t\t\t\tdata-margin=\"r:160,50,50,30;b:50,50,50,30;l:160,50,50,30;\"\n\t\t\t\t\t\t\t\t\tdata-frame_0=\"y:100%;\"\n\t\t\t\t\t\t\t\t\tdata-frame_0_mask=\"u:t;\"\n\t\t\t\t\t\t\t\t\tdata-frame_0_reverse=\"y:true;\"\n\t\t\t\t\t\t\t\t\tdata-frame_1=\"st:200;sp:1300;\"\n\t\t\t\t\t\t\t\t\tdata-frame_1_mask=\"u:t;\"\n\t\t\t\t\t\t\t\t\tdata-frame_999=\"y:-100%;o:0;st:w;sp:800;sA:9000;\"\n\t\t\t\t\t\t\t\t\tdata-frame_999_mask=\"u:t;\"\n\t\t\t\t\t\t\t\t\tdata-frame_999_reverse=\"y:true;\"\n\t\t\t\t\t\t\t\t\tstyle=\"z-index:6;\"\n\t\t\t\t\t\t\t\t><!--\n\t\t\t\t\t\t\t\t\t--><rs-column\n\t\t\t\t\t\t\t\t\t\tid=\"slider-96-slide-141-layer-5\" \n\t\t\t\t\t\t\t\t\t\tdata-type=\"column\"\n\t\t\t\t\t\t\t\t\t\tdata-xy=\"xo:50px;yo:50px;\"\n\t\t\t\t\t\t\t\t\t\tdata-rsp_bd=\"off\"\n\t\t\t\t\t\t\t\t\t\tdata-column=\"w:66.67%;\"\n\t\t\t\t\t\t\t\t\t\tdata-frame_0=\"o:1;\"\n\t\t\t\t\t\t\t\t\t\tdata-frame_999=\"o:1;st:w;sp:800;sA:9000;\"\n\t\t\t\t\t\t\t\t\t\tstyle=\"z-index:7;width:100%;\"\n\t\t\t\t\t\t\t\t\t><!--\n\t\t\t\t\t\t\t\t\t\t--><rs-layer\n\t\t\t\t\t\t\t\t\t\t\tid=\"slider-96-slide-141-layer-8\" \n\t\t\t\t\t\t\t\t\t\t\tdata-type=\"text\"\n\t\t\t\t\t\t\t\t\t\t\tdata-rsp_ch=\"on\"\n\t\t\t\t\t\t\t\t\t\t\tdata-xy=\"\"\n\t\t\t\t\t\t\t\t\t\t\tdata-pos=\"r\"\n\t\t\t\t\t\t\t\t\t\t\tdata-text=\"w:normal;s:40,35,30,24;l:40,35,40,30;fw:700;a:left,left,left,center;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-frame_999=\"o:1;st:w;sp:800;\"\n\t\t\t\t\t\t\t\t\t\t\tstyle=\"z-index:9;font-family:'Roboto';\"\n\t\t\t\t\t\t\t\t\t\t>$650 \n\t\t\t\t\t\t\t\t\t\t<\/rs-layer><!--\n\n\t\t\t\t\t\t\t\t\t\t--><rs-layer\n\t\t\t\t\t\t\t\t\t\t\tid=\"slider-96-slide-141-layer-9\" \n\t\t\t\t\t\t\t\t\t\t\tdata-type=\"text\"\n\t\t\t\t\t\t\t\t\t\t\tdata-rsp_ch=\"on\"\n\t\t\t\t\t\t\t\t\t\t\tdata-xy=\"\"\n\t\t\t\t\t\t\t\t\t\t\tdata-pos=\"r\"\n\t\t\t\t\t\t\t\t\t\t\tdata-text=\"w:normal;s:18,16,15,14;l:40,35,40,35;a:left,left,left,center;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-margin=\"t:15,12,9,6;b:15,12,9,6;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-frame_999=\"o:1;st:w;sp:800;\"\n\t\t\t\t\t\t\t\t\t\t\tstyle=\"z-index:8;font-family:'IBM Plex Mono';\"\n\t\t\t\t\t\t\t\t\t\t><i class=\"material-icons\">star<\/i><i class=\"material-icons\">star<\/i><i class=\"material-icons\">star<\/i><i class=\"material-icons\">star<\/i><i class=\"material-icons\">star<\/i> \n\t\t\t\t\t\t\t\t\t\t<\/rs-layer><!--\n\n\t\t\t\t\t\t\t\t\t\t--><rs-layer\n\t\t\t\t\t\t\t\t\t\t\tid=\"slider-96-slide-141-layer-10\" \n\t\t\t\t\t\t\t\t\t\t\tdata-type=\"text\"\n\t\t\t\t\t\t\t\t\t\t\tdata-color=\"rgba(255, 255, 255, 0.7)\"\n\t\t\t\t\t\t\t\t\t\t\tdata-rsp_ch=\"on\"\n\t\t\t\t\t\t\t\t\t\t\tdata-xy=\"\"\n\t\t\t\t\t\t\t\t\t\t\tdata-pos=\"r\"\n\t\t\t\t\t\t\t\t\t\t\tdata-text=\"w:normal;s:22,16,16,25;l:30;a:left,left,left,center;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-margin=\"t:0,0,0,10;b:0,0,0,15;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-padding=\"r:100,83,0,0;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-frame_999=\"o:1;st:w;sp:800;\"\n\t\t\t\t\t\t\t\t\t\t\tstyle=\"z-index:7;font-family:'Roboto';\"\n\t\t\t\t\t\t\t\t\t\t><i class=\"fa-info-circle\"><\/i> 42 hours - <b>Synchronous virtual mode<\/b><br \/>\n<i class=\"fa-calendar\"><\/i> <b>Start:<\/b> 5 de Mayo 2025 \n\t\t\t\t\t\t\t\t\t\t<\/rs-layer><!--\n\n\t\t\t\t\t\t\t\t\t\t--><rs-layer\n\t\t\t\t\t\t\t\t\t\t\tid=\"slider-96-slide-141-layer-1\" \n\t\t\t\t\t\t\t\t\t\t\tdata-type=\"image\"\n\t\t\t\t\t\t\t\t\t\t\tdata-rsp_ch=\"on\"\n\t\t\t\t\t\t\t\t\t\t\tdata-xy=\"yo:0,100px,220px,240px;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-pos=\"a\"\n\t\t\t\t\t\t\t\t\t\t\tdata-text=\"w:normal;s:20,16,12,7;l:0,20,15,9;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-dim=\"w:830px,685px,520px,320px;h:83px,68px,51px,31px;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-frame_0=\"x:left;o:1;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-frame_0_reverse=\"x:true;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-frame_1=\"o:0.6;e:power2.inOut;st:200;sp:1300;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-frame_999=\"x:right;o:1;st:w;sp:800;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-frame_999_reverse=\"x:true;\"\n\t\t\t\t\t\t\t\t\t\t\tstyle=\"z-index:6;\"\n\t\t\t\t\t\t\t\t\t\t><img fetchpriority=\"high\" decoding=\"async\" src=\"\/\/pxsglobal.com\/wp-content\/plugins\/revslider\/public\/assets\/assets\/dummy.png\" alt=\"\" class=\"tp-rs-img rs-lazyload\" width=\"830\" height=\"83\" data-lazyload=\"\/\/pxsglobal.com\/wp-content\/uploads\/revslider\/woocommerce-slider-static\/shadow1.png\" data-no-retina> \n\t\t\t\t\t\t\t\t\t\t<\/rs-layer><!--\n\t\t\t\t\t\t\t\t\t--><\/rs-column><!--\n\n\t\t\t\t\t\t\t\t\t--><rs-column\n\t\t\t\t\t\t\t\t\t\tid=\"slider-96-slide-141-layer-6\" \n\t\t\t\t\t\t\t\t\t\tdata-type=\"column\"\n\t\t\t\t\t\t\t\t\t\tdata-xy=\"xo:50px;yo:50px;\"\n\t\t\t\t\t\t\t\t\t\tdata-text=\"a:right,right,right,center;\"\n\t\t\t\t\t\t\t\t\t\tdata-rsp_bd=\"off\"\n\t\t\t\t\t\t\t\t\t\tdata-column=\"a:bottom;\"\n\t\t\t\t\t\t\t\t\t\tdata-frame_0=\"o:1;\"\n\t\t\t\t\t\t\t\t\t\tdata-frame_999=\"o:1;st:w;sp:800;sA:9000;\"\n\t\t\t\t\t\t\t\t\t\tstyle=\"z-index:6;width:100%;\"\n\t\t\t\t\t\t\t\t\t><!--\n\t\t\t\t\t\t\t\t\t\t--><rs-layer\n\t\t\t\t\t\t\t\t\t\t\tid=\"slider-96-slide-141-layer-11\" \n\t\t\t\t\t\t\t\t\t\t\tclass=\"rev-btn\"\n\t\t\t\t\t\t\t\t\t\t\tdata-type=\"button\"\n\t\t\t\t\t\t\t\t\t\t\tdata-rsp_ch=\"on\"\n\t\t\t\t\t\t\t\t\t\t\tdata-xy=\"\"\n\t\t\t\t\t\t\t\t\t\t\tdata-pos=\"r\"\n\t\t\t\t\t\t\t\t\t\t\tdata-text=\"w:normal;s:30,24,24,20;l:60,60,60,39;ls:4px,3px,2px,1px;fw:700;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-dim=\"minh:0px,none,none,none;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-actions='id:matricular;o:click;a:scrollto;sp:1000ms;e:power1.inOut;'\n\t\t\t\t\t\t\t\t\t\t\tdata-disp=\"inline-block\"\n\t\t\t\t\t\t\t\t\t\t\tdata-border=\"bos:solid;boc:rgba(255,255,255,0.35);bow:0px,0px,1px,0px;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-frame_999=\"o:1;st:w;sp:800;\"\n\t\t\t\t\t\t\t\t\t\t\tdata-frame_hover=\"bgc:rgba(0,0,0,0);boc:rgba(255,255,255,0.75);bor:0px,0px,0px,0px;bos:solid;bow:0px,0px,1px,0px;e:power1.inOut;\"\n\t\t\t\t\t\t\t\t\t\t\tstyle=\"z-index:6;background-color:rgba(0,0,0,0);font-family:'Roboto';text-transform:uppercase;display:inline-block;\"\n\t\t\t\t\t\t\t\t\t\t>Enroll \n\t\t\t\t\t\t\t\t\t\t<\/rs-layer><!--\n\t\t\t\t\t\t\t\t\t--><\/rs-column><!--\n\t\t\t\t\t\t\t\t--><\/rs-row><!--\n\t\t\t\t\t\t\t--><\/rs-zone><!--\n\n\t\t\t\t\t\t\t--><rs-layer\n\t\t\t\t\t\t\t\tid=\"slider-96-slide-141-layer-0\" \n\t\t\t\t\t\t\t\tclass=\"rs-pxl-1\"\n\t\t\t\t\t\t\t\tdata-type=\"image\"\n\t\t\t\t\t\t\t\tdata-rsp_ch=\"on\"\n\t\t\t\t\t\t\t\tdata-xy=\"x:c;y:m;yo:0,0,0,-60px;\"\n\t\t\t\t\t\t\t\tdata-text=\"w:normal;s:20,16,12,7;l:0,20,15,9;\"\n\t\t\t\t\t\t\t\tdata-dim=\"w:662px,422px,365px,298px;h:372px,365px,316px,258px;\"\n\t\t\t\t\t\t\t\tdata-basealign=\"slide\"\n\t\t\t\t\t\t\t\tdata-frame_0=\"x:left;o:1;\"\n\t\t\t\t\t\t\t\tdata-frame_0_reverse=\"x:true;\"\n\t\t\t\t\t\t\t\tdata-frame_1=\"e:power2.inOut;st:200;sp:1500;\"\n\t\t\t\t\t\t\t\tdata-frame_999=\"x:right;o:1;st:w;sp:800;\"\n\t\t\t\t\t\t\t\tdata-frame_999_reverse=\"x:true;\"\n\t\t\t\t\t\t\t\tdata-loop_0=\"y:-10;\"\n\t\t\t\t\t\t\t\tdata-loop_999=\"y:10;sp:6000;e:sine.inOut;yym:t;\"\n\t\t\t\t\t\t\t\tstyle=\"z-index:8;\"\n\t\t\t\t\t\t\t><img decoding=\"async\" src=\"\/\/pxsglobal.com\/wp-content\/plugins\/revslider\/public\/assets\/assets\/dummy.png\" alt=\"\" class=\"tp-rs-img rs-lazyload\" width=\"1366\" height=\"768\" data-lazyload=\"\/\/pxsglobal.com\/wp-content\/uploads\/2024\/05\/PXS-ASQ.png\" data-no-retina> \n\t\t\t\t\t\t\t<\/rs-layer><!--\n-->\t\t\t\t\t\t<\/rs-slide>\n\t\t\t\t\t<\/rs-slides>\n\t\t\t\t\t<rs-static-layers><!--\n\n\t\t\t\t\t\t\t--><rs-layer\n\t\t\t\t\t\t\t\tid=\"slider-96-slide-95-layer-24\" \n\t\t\t\t\t\t\t\tclass=\"rs-layer-static\"\n\t\t\t\t\t\t\t\tdata-type=\"text\"\n\t\t\t\t\t\t\t\tdata-xy=\"xo:78px,50px,50px,50px;yo:426px,40px,40px,40px;\"\n\t\t\t\t\t\t\t\tdata-text=\"w:normal;s:26,26,25,25;l:40,35,35,35;ls:3px;fw:700;\"\n\t\t\t\t\t\t\t\tdata-basealign=\"slide\"\n\t\t\t\t\t\t\t\tdata-rsp_o=\"off\"\n\t\t\t\t\t\t\t\tdata-rsp_bd=\"off\"\n\t\t\t\t\t\t\t\tdata-onslides=\"s:1;\"\n\t\t\t\t\t\t\t\tdata-frame_0=\"x:left;\"\n\t\t\t\t\t\t\t\tdata-frame_1=\"e:power2.inOut;st:300;sp:1200;\"\n\t\t\t\t\t\t\t\tdata-frame_999=\"o:0;st:w;\"\n\t\t\t\t\t\t\t\tstyle=\"z-index:6;font-family:'Roboto Condensed';text-transform:uppercase;\"\n\t\t\t\t\t\t\t>Quality \n\t\t\t\t\t\t\t<\/rs-layer><!--\n\t\t\t\t\t--><\/rs-static-layers>\n\t\t\t\t<\/rs-module>\n\t\t\t\t<script>\n\t\t\t\t\tsetREVStartSize({c: 'rev_slider_96_1',rl:[1240,1024,778,480],el:[900,768,960,720],gw:[1240,1024,778,480],gh:[900,768,960,720],type:'standard',justify:'',layout:'fullscreen',offsetContainer:'#masthead',offset:'',mh:\"0\"});if (window.RS_MODULES!==undefined && window.RS_MODULES.modules!==undefined && window.RS_MODULES.modules[\"revslider961\"]!==undefined) {window.RS_MODULES.modules[\"revslider961\"].once = false;window.revapi96 = undefined;if (window.RS_MODULES.checkMinimal!==undefined) window.RS_MODULES.checkMinimal()}\n\t\t\t\t<\/script>\n\t\t\t<\/rs-module-wrap>\n\t\t\t<!-- END REVOLUTION SLIDER -->\n<\/div>\n\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-ccd284e elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"ccd284e\" data-element_type=\"section\" id=\"descripcion\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t\t<div class=\"elementor-background-overlay\"><\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-wider\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-7d57576\" data-fullscreen-column-settings=\"{&quot;fullscreen&quot;:&quot;&quot;}\" data-id=\"7d57576\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-9107b24 elementor-widget elementor-widget-heading\" data-id=\"9107b24\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h5 class=\"elementor-heading-title elementor-size-default\">CURSO DE PREPARACI\u00d3N PARA LA CERTIFICACI\u00d3N DE AUDITOR DE DISPOSITIVOS M\u00c9DICOS<\/h5>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6aea03c elementor-widget elementor-widget-spacer\" data-id=\"6aea03c\" data-element_type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-73b4605 elementor-invisible elementor-widget elementor-widget-litho-drop-cap\" data-id=\"73b4605\" data-element_type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInDown&quot;}\" data-widget_type=\"litho-drop-cap.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-text-editor elementor-clearfix\"><h5 style=\"color: #ff6e2f;text-align: left\"><strong>DESCRIPTION:<\/strong><\/h5><div><strong>\u00a0<\/strong><\/div><p><strong>\u00bfPOR QU\u00c9 CONVERTIRSE EN UN AUDITOR DE DISPOSITIVOS M\u00c9DICOS CERTIFICADO?<\/strong><\/p><p>Como Auditor Certificado de Dispositivos M\u00e9dicos (CMDA), ser\u00e1 un profesional que comprende los principios de los est\u00e1ndares, regulaciones, directivas y orientaci\u00f3n para auditar un sistema de dispositivos m\u00e9dicos mientras utiliza diversas herramientas y t\u00e9cnicas para examinar, cuestionar, evaluar e informar sobre las adecuaciones y deficiencias de ese sistema. Un CMDA analiza todos los elementos del sistema e informa sobre el grado en que se adhiere a los criterios de gesti\u00f3n y control de la seguridad de los procesos.<\/p><p><strong>\u00bfCU\u00c1LES SON LAS COMPETENCIAS B\u00c1SICAS DE UN CMDA?<\/strong><\/p><p>Comprender los diferentes tipos de auditor\u00edas, las funciones y responsabilidades de la auditor\u00eda, y los problemas \u00e9ticos, legales y profesionales asociados con las auditor\u00edas.<\/p><p>Aplicar y comprender una amplia variedad de requisitos del sistema de gesti\u00f3n de calidad de dispositivos m\u00e9dicos, incluidas las leyes y regulaciones regulatorias de EE. UU. y extranjeras (por ejemplo, C\u00f3digo de Regulaciones Federales, 21 CFR 820) y est\u00e1ndares internacionales de calidad (por ejemplo, ISO 9001, ISO 13485).<\/p><p>Comprenda las herramientas de calidad, como los diagramas de Pareto, los diagramas de causa y efecto, los diagramas de flujo, los gr\u00e1ficos de control estad\u00edstico de procesos (SPC), las hojas de comprobaci\u00f3n, los diagramas de dispersi\u00f3n, los histogramas y el plan-hacer-verificar-actuar (PDCA).<\/p><p>Identificar y aplicar normas relacionadas con la gesti\u00f3n de riesgos, la detecci\u00f3n de peligros y la esterilizaci\u00f3n para productos procesados as\u00e9pticamente y esterilizados terminalmente.<\/p><p>Eval\u00fae los programas de gesti\u00f3n de riesgos y los requisitos para el manejo de quejas, la vigilancia, los informes de dispositivos m\u00e9dicos (MDR) y los procesos de seguimiento y retiro de productos. Revisar los procedimientos de validaci\u00f3n para las pruebas de laboratorio y utilizar los m\u00e9todos adecuados para analizar, detectar y controlar las no conformidades.<\/p><p>Identificar y describir los t\u00e9rminos de biocompatibilidad y la justificaci\u00f3n de la selecci\u00f3n de pruebas de acuerdo con las normas y directrices aplicables. Eval\u00fae los controles ambientales y determine si los servicios p\u00fablicos requieren calificaci\u00f3n, validaci\u00f3n o mantenimiento.<\/p><p style=\"text-align: left\">Reconocer los elementos del ciclo de vida del desarrollo de software para productos, procesos y sistemas de calidad.<\/p><\/div> \t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-081f390 elementor-widget elementor-widget-spacer\" data-id=\"081f390\" data-element_type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2b07760 elementor-widget elementor-widget-n-accordion\" data-id=\"2b07760\" data-element_type=\"widget\" data-settings=\"{&quot;default_state&quot;:&quot;expanded&quot;,&quot;max_items_expended&quot;:&quot;one&quot;,&quot;n_accordion_animation_duration&quot;:{&quot;unit&quot;:&quot;ms&quot;,&quot;size&quot;:400,&quot;sizes&quot;:[]}}\" data-widget_type=\"nested-accordion.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"e-n-accordion\" aria-label=\"Accordion. Open links with Enter or Space, close with Escape, and navigate with Arrow Keys\">\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-4510\" class=\"e-n-accordion-item\" open>\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"1\" tabindex=\"0\" aria-expanded=\"true\" aria-controls=\"e-n-accordion-item-4510\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> I. Auditing Fundamentals <\/div><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-minus\" viewbox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h384c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t\t<span class='e-closed'><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-plus\" viewbox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H272V64c0-17.67-14.33-32-32-32h-32c-17.67 0-32 14.33-32 32v144H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h144v144c0 17.67 14.33 32 32 32h32c17.67 0 32-14.33 32-32V304h144c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-4510\" class=\"elementor-element elementor-element-cf4b263 e-con-full e-flex e-con e-child\" data-id=\"cf4b263\" data-element_type=\"container\">\n\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-4510\" class=\"elementor-element elementor-element-de3e7f6 e-flex e-con-boxed e-con e-child\" data-id=\"de3e7f6\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-72c7c3d elementor-widget elementor-widget-text-editor\" data-id=\"72c7c3d\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><strong>A. Tipos de Auditor\u00eda:<\/strong><\/p><ul><li>Auditor\u00edas por m\u00e9todo<\/li><li>Auditor\u00edas por prop\u00f3sito.<\/li><\/ul><p><strong>B. Funciones y responsabilidades de la auditor\u00eda.<\/strong><\/p><p><strong>C. \u00c9tico, legalidad y problemas profesionales<\/strong><\/p><ul><li>Conducta y responsabilidades profesionales.<\/li><li>Consecuencias legales y responsabilidad.<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-4511\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"2\" tabindex=\"-1\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-4511\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> II. Conocimiento t\u00e9cnico biom\u00e9dico <\/div><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-minus\" viewbox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h384c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t\t<span class='e-closed'><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-plus\" viewbox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H272V64c0-17.67-14.33-32-32-32h-32c-17.67 0-32 14.33-32 32v144H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h144v144c0 17.67 14.33 32 32 32h32c17.67 0 32-14.33 32-32V304h144c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-4511\" class=\"elementor-element elementor-element-f293cc2 e-con-full e-flex e-con e-child\" data-id=\"f293cc2\" data-element_type=\"container\">\n\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-4511\" class=\"elementor-element elementor-element-2759ad6 e-flex e-con-boxed e-con e-child\" data-id=\"2759ad6\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-4057ef7 elementor-widget elementor-widget-text-editor\" data-id=\"4057ef7\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><strong>A. Preparaci\u00f3n y planificaci\u00f3n de auditor\u00edas:<\/strong><\/p><ul><li>Elementos del proceso de planificaci\u00f3n de auditor\u00eda.<\/li><li>Selecci\u00f3n del auditor.<\/li><li>Documentaci\u00f3n relacionada con la auditor\u00eda.<\/li><li>Herramientas de auditor\u00eda.<\/li><li>Estrategias de auditor\u00eda.<\/li><li>Logistics.<\/li><\/ul><p><strong>B. Rendimiento de auditor\u00eda<\/strong><\/p><ul><li>Reuni\u00f3n de apertura.<\/li><li>Recogida y an\u00e1lisis de datos.<\/li><li>T\u00e9cnicas de comunicaci\u00f3n.<\/li><li>Organizaci\u00f3n y an\u00e1lisis de evidencia objetiva.<\/li><li>Gesti\u00f3n de auditor\u00eda en el sitio.<\/li><li>Salir de la reuni\u00f3n.<\/li><\/ul><p><strong>C. Informes de auditor\u00eda<\/strong><\/p><ul><li>Elementos b\u00e1sicos.<\/li><li>Informes de auditor\u00eda efectivos.<\/li><li>Retenci\u00f3n de registros.<\/li><\/ul><p><strong>D. Seguimiento de auditor\u00eda y cierre<\/strong><\/p><ul><li>Elementos de las acciones correctivas y preventivas.<\/li><li>Revisi\u00f3n del plan de acci\u00f3n correctiva.<\/li><li>Realizaci\u00f3n de seguimiento de auditor\u00eda.<\/li><li>Cierre de auditor\u00eda.<\/li><\/ul><p><strong>E. Referencias de procedimiento de auditor\u00eda<\/strong><\/p><ul><li>Directrices internacionales para auditar sistemas de calidad.<\/li><li>Quality System InspectionTechnique (QSIT) y FDA CPG 7382.845.<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-4512\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"3\" tabindex=\"-1\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-4512\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> III. Requisitos del sistema de gesti\u00f3n de calidad biom\u00e9dica <\/div><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-minus\" viewbox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h384c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t\t<span class='e-closed'><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-plus\" viewbox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H272V64c0-17.67-14.33-32-32-32h-32c-17.67 0-32 14.33-32 32v144H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h144v144c0 17.67 14.33 32 32 32h32c17.67 0 32-14.33 32-32V304h144c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-4512\" class=\"elementor-element elementor-element-1bf2bc4 e-con-full e-flex e-con e-child\" data-id=\"1bf2bc4\" data-element_type=\"container\">\n\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-4512\" class=\"elementor-element elementor-element-afb281e e-flex e-con-boxed e-con e-child\" data-id=\"afb281e\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-46f4ad5 elementor-widget elementor-widget-text-editor\" data-id=\"46f4ad5\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><strong>A. Leyes regulatorias y requisitos<\/strong><\/p><ul><li>FDA &#8211; C\u00f3digo de Regulaciones Federales (CFR) T\u00edtulo 21.<\/li><li>Requisitos de EE. UU. (Ley FD &amp; C, 201, 301-304, 501-502, 510, 513, 518, 704).<\/li><li>Directiva europea: Directiva sobre dispositivos m\u00e9dicos 93\/42 \/ EEC (MDD) 14 de junio de 1993 (Art\u00edculo 1) modificada por la Directiva 2007\/47 \/ CE..<\/li><li>Health Canada.<\/li><li>Jap\u00f3n.<\/li><li>Otras agencias internacionales.<\/li><\/ul><p><strong>B. Gu\u00eda de la FDA para la fabricaci\u00f3n de productos (IVD)<\/strong><\/p><p><strong>C. Est\u00e1ndares internacionales para sistemas de calidad<\/strong><\/p><ul><li>ISO 9001, ISO 13485, ISO 17025.<\/li><li>GHTF.SG3.N99-10.<\/li><\/ul><p><strong>D. Requisitos de Regulaci\u00f3n del Sistema de Calidad (QSR) (21 CFR 820 &#8211; Partes como se muestra)<\/strong><\/p><ul><li>Responsabilidad de gesti\u00f3n (Partes 20, 22, 25).<\/li><li>Sistema de control de dise\u00f1o (Parte 30).<\/li><li>Documento (Parte 40) y control de registro (Partes 180-186).<\/li><li>Controles de compra y actividades de aceptaci\u00f3n (Partes 50, 80, 86).<\/li><li>Identificaci\u00f3n y trazabilidad (Partes 60, 65).<\/li><li>Controles de producci\u00f3n y proceso (Partes 70, 72, 75).<\/li><li>Producto no conforme (Parte 90).<\/li><li>Sistema de acci\u00f3n correctiva y preventiva (CAPA) (Parte 100).<\/li><li>Manejo, almacenamiento, distribuci\u00f3n e instalaci\u00f3n del producto (Partes 140-170).<\/li><li>Servicio (Parte 200).<\/li><li>T\u00e9cnicas estad\u00edsticas (Parte 250) .<\/li><\/ul><p><strong>E. Vigilancia posterior al mercado (Orientaci\u00f3n bajo la Secci\u00f3n 522 de la Ley FD &amp; C)<\/strong><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-4513\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"4\" tabindex=\"-1\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-4513\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> IV. Conocimiento biom\u00e9dico t\u00e9cnico <\/div><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-minus\" viewbox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h384c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t\t<span class='e-closed'><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-plus\" viewbox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H272V64c0-17.67-14.33-32-32-32h-32c-17.67 0-32 14.33-32 32v144H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h144v144c0 17.67 14.33 32 32 32h32c17.67 0 32-14.33 32-32V304h144c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-4513\" class=\"elementor-element elementor-element-29ca126 e-con-full e-flex e-con e-child\" data-id=\"29ca126\" data-element_type=\"container\">\n\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-4513\" class=\"elementor-element elementor-element-d21a26d e-flex e-con-boxed e-con e-child\" data-id=\"d21a26d\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-3a93078 elementor-widget elementor-widget-text-editor\" data-id=\"3a93078\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><strong>A. Gesti\u00f3n de riesgos<\/strong><\/p><ul><li>ISO 14971.<\/li><li>IEC 62366.<\/li><\/ul><p><strong>B. Esterilizaci\u00f3n<\/strong><\/p><ul><li>Definiciones.<\/li><li>M\u00e9todos y controles de proceso.<\/li><\/ul><p><strong>C. Biocompatibilidad<\/strong><\/p><p><strong>D. Ambientes controlados y sistemas de utilidad<\/strong><\/p><ul><li>Ambientes controlados.<\/li><li>Sistemas de utilidad.<\/li><\/ul><p><strong>E. Desarrollo y mantenimiento de software para productos<\/strong><\/p><p><strong>F. Pruebas de laboratorio y an\u00e1lisis de fallas<\/strong><\/p><p><strong>G. Fuentes para est\u00e1ndares nuevos y en desarrollo<\/strong><\/p><p><strong>H. Directivas y est\u00e1ndares comunes de dispositivos m\u00e9dicos<\/strong><\/p><ul><li>IEC 60601-1 and IEC 80001.<\/li><li>Directiva de Restricci\u00f3n de Sustancias Peligrosas (RoHS).<\/li><li>Registro, Evaluaci\u00f3n, Autorizaci\u00f3n y Restricci\u00f3n de Productos Qu\u00edmicos (REACH).<\/li><li>Residuos de aparatos el\u00e9ctricos y electr\u00f3nicos (RAEE).<\/li><\/ul><p><strong>I. Packaging<\/strong><\/p><p><strong>J. Reprocesamiento \/ Reutilizaci\u00f3n y limpieza de dispositivos m\u00e9dicos<\/strong><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-4514\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"5\" tabindex=\"-1\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-4514\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> V. Herramientas y t\u00e9cnicas de calidad <\/div><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-minus\" viewbox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h384c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t\t<span class='e-closed'><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-plus\" viewbox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H272V64c0-17.67-14.33-32-32-32h-32c-17.67 0-32 14.33-32 32v144H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h144v144c0 17.67 14.33 32 32 32h32c17.67 0 32-14.33 32-32V304h144c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-4514\" class=\"elementor-element elementor-element-6989196 e-con-full e-flex e-con e-child\" data-id=\"6989196\" data-element_type=\"container\">\n\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-4514\" class=\"elementor-element elementor-element-a44e554 e-flex e-con-boxed e-con e-child\" data-id=\"a44e554\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-734afcd elementor-widget elementor-widget-text-editor\" data-id=\"734afcd\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><strong>A. Process Improvement Techniques<\/strong><\/p><ul><li>ISO 14971.<\/li><li>IEC 62366.<\/li><\/ul><p><strong>B. T\u00e9cnicas de mejora de procesos<\/strong><\/p><ul><li>Capacidad de procesamiento.<\/li><li>Six Sigma.<\/li><li>Lean Tools.<\/li><li>Measurement System Analysis (MSA).<\/li><li>Costos de Calidad (COQ).<\/li><\/ul><p><strong>C. 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       <script id=\"tmpl-nf-mp-form-content\" type=\"text\/template\">\n\t<div class=\"nf-mp-header\"><\/div>\n\t<div class=\"nf-mp-body\"><\/div>\n\t<div class=\"nf-mp-footer\"><\/div>\n<\/script>\n\n\n<script id=\"tmpl-nf-mp-header\" type=\"text\/template\">\n\t{{{ data.renderProgressBar() }}}\n\t{{{ data.renderBreadcrumbs() }}}\n\t{{{ data.renderPartTitle() }}}\n<\/script>\n<script id=\"tmpl-nf-mp-part-title\" type=\"text\/template\">\n\t<h3>\n\t\t{{{ data.title }}}\n\t<\/h3>\n<\/script>\n\n<script id=\"tmpl-nf-mp-footer\" type=\"text\/template\">\n\t{{{ data.renderNextPrevious() }}}\n<\/script>\n\n<script id=\"tmpl-nf-mp-next-previous\" type=\"text\/template\">\n\t<ul class=\"nf-next-previous\">\n\t\t<# if ( data.showPrevious ) { #>\n\t\t<li class=\"nf-previous-item\">\n\t\t\t<input type=\"button\" class=\"nf-previous\" value=\"{{{ data.prevLabel }}}\" \/>\n\t\t<\/li>\n\t\t<# } #>\n\n\t\t<# if ( data.showNext ) { #>\n\t\t<li class=\"nf-next-item\">\n\t\t\t<input type=\"button\" 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'' : '' }}} {{{ part.title }}}<\/a>\n\t\t<\/li>\n\t\t<# } ); #>\n\t<\/ul>\n<\/script>\n\n<script id=\"tmpl-nf-mp-progress-bar\" type=\"text\/template\">\n    <div class=\"nf-progress-container\">\n        <div class=\"nf-progress\" style=\"width: {{{ data.percent }}}%;\"><\/div>\n    <\/div>\n<\/script>        <script id=\"nf-tmpl-cell\" type=\"text\/template\">\n            <nf-fields><\/nf-fields>\n        <\/script>\n\n        <script id=\"nf-tmpl-row\" type=\"text\/template\">\n            <nf-cells><\/nf-cells>\n        <\/script>\n\n        <\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c206656 elementor-invisible elementor-widget elementor-widget-litho-drop-cap\" data-id=\"c206656\" data-element_type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInDown&quot;}\" data-widget_type=\"litho-drop-cap.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-text-editor elementor-clearfix\"><p><strong>\u00bfCU\u00c1L ES EL VALOR PARA SU EMPRESA TENER UN INTEGRANTE CON CONOCIMIENTOS DE CMDA?<\/strong><\/p><p>Garantizar la conformidad con los est\u00e1ndares de la industria y el cumplimiento de las regulaciones y requisitos relacionados con los sistemas de calidad, quejas, MDR, clasificaci\u00f3n de productos y m\u00e1s.<\/p><p>Comprender las herramientas de auditor\u00eda de la industria, como la T\u00e9cnica de Inspecci\u00f3n del Sistema de Calidad (QSIT) de la FDA y la auditor\u00eda basada en riesgos.<\/p><p>Mitigar los riesgos costosos utilizando m\u00e9todos y procesos de esterilizaci\u00f3n adecuados.<\/p><p>Mejorar los procesos mediante la implementaci\u00f3n de herramientas y t\u00e9cnicas de calidad.<\/p><p><strong>\u00bfCU\u00c1L ES EL VALOR PARA TI ESTAR ENTRENADO Y CERTIFICADO COMO CMDA?<\/strong><\/p><p>Un conjunto de habilidades mejorado lo califica para m\u00e1s puestos dentro de los entornos comerciales modernos.<\/p><p>Los CMDA con un t\u00edtulo de trabajo de auditor ganan un promedio de $96,827 por a\u00f1o, en comparaci\u00f3n con los auditores sin certificaci\u00f3n, que ganan aproximadamente $73,975.<\/p><\/div> \t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3e43aba elementor-invisible elementor-widget elementor-widget-litho-drop-cap\" data-id=\"3e43aba\" data-element_type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInDown&quot;}\" data-widget_type=\"litho-drop-cap.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-text-editor elementor-clearfix\"><p><strong>INFORMACI\u00d3N DEL MERCADO DONDE LABORA UN CMDA<\/strong><\/p><\/div> \t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-592afd7 elementor-widget elementor-widget-image\" data-id=\"592afd7\" data-element_type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<a href=\"https:\/\/pxsglobal.com\/wp-content\/uploads\/2025\/01\/table.png\" data-elementor-open-lightbox=\"yes\" data-elementor-lightbox-title=\"table\" data-e-action-hash=\"#elementor-action%3Aaction%3Dlightbox%26settings%3DeyJpZCI6ODM2NTEsInVybCI6Imh0dHBzOlwvXC9weHNnbG9iYWwuY29tXC93cC1jb250ZW50XC91cGxvYWRzXC8yMDI1XC8wMVwvdGFibGUucG5nIn0%3D\">\n\t\t\t\t\t\t\t<img loading=\"lazy\" decoding=\"async\" width=\"884\" height=\"330\" src=\"https:\/\/pxsglobal.com\/wp-content\/uploads\/2025\/01\/table.png\" class=\"attachment-large size-large wp-image-83651\" alt=\"\" srcset=\"https:\/\/pxsglobal.com\/wp-content\/uploads\/2025\/01\/table.png 884w, https:\/\/pxsglobal.com\/wp-content\/uploads\/2025\/01\/table-300x112.png 300w, https:\/\/pxsglobal.com\/wp-content\/uploads\/2025\/01\/table-768x287.png 768w, https:\/\/pxsglobal.com\/wp-content\/uploads\/2025\/01\/table-18x7.png 18w, https:\/\/pxsglobal.com\/wp-content\/uploads\/2025\/01\/table-200x75.png 200w, https:\/\/pxsglobal.com\/wp-content\/uploads\/2025\/01\/table-600x224.png 600w\" sizes=\"(max-width: 884px) 100vw, 884px\" \/>\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-198b885 elementor-widget elementor-widget-spacer\" data-id=\"198b885\" data-element_type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2f960ec elementor-widget elementor-widget-text-editor\" data-id=\"2f960ec\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"color: #000000;\"><strong>TENDENCIAS CLAVE DEL MERCADOS CLAVE DE UN CMDA<\/strong><\/span><\/p><ul><li><span style=\"color: #000000;\">Gesti\u00f3n de riesgos (ISO 14971)<\/span><\/li><li><span style=\"color: #000000;\">Toma de decisiones basada en el riesgo<\/span><\/li><li><span style=\"color: #000000;\">Cumplimiento de la norma FDA 21 CFR 820<\/span><\/li><li><span style=\"color: #000000;\">ISO 13485<\/span><\/li><\/ul><p><span style=\"color: #000000;\"><b>IMPORTANTE<\/b><\/span><\/p><p>El participante debe tener conocimientos en el idioma ingl\u00e9s ya que el material y el examen son en este idioma.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-93a2ebb elementor-widget elementor-widget-spacer\" data-id=\"93a2ebb\" data-element_type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-3a74d2d elementor-section-full_width elementor-section-height-default elementor-section-height-default\" data-id=\"3a74d2d\" data-element_type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-25 elementor-top-column elementor-element elementor-element-414ede8 elementor-invisible\" data-fullscreen-column-settings=\"{&quot;fullscreen&quot;:&quot;&quot;}\" data-id=\"414ede8\" data-element_type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;animation&quot;:&quot;fadeIn&quot;,&quot;animation_delay&quot;:200}\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-25 elementor-top-column elementor-element elementor-element-6f227d1\" data-fullscreen-column-settings=\"{&quot;fullscreen&quot;:&quot;&quot;}\" data-id=\"6f227d1\" data-element_type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-eedd252 elementor-widget elementor-widget-spacer\" data-id=\"eedd252\" data-element_type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c04e1b6 elementor-widget elementor-widget-litho-heading\" data-id=\"c04e1b6\" data-element_type=\"widget\" data-widget_type=\"litho-heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h4 class=\"litho-heading elementor-size-default\"><span class=\"litho-primary-title\">C\u00f3mo establecer los requerimientos de la vestimenta<\/span><span class=\"litho-secondary-title\"> en los cuartos limpios<\/span><\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a81b729 elementor-widget__width-initial elementor-widget-tablet__width-initial elementor-widget-mobile__width-inherit elementor-widget elementor-widget-text-editor\" data-id=\"a81b729\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>En este blog le explicamos c\u00f3mo usar la norma ISO 14644-5:2004 Cuartos limpios y entornos controlados asociados \u2013 Operaciones para establecer los requerimientos para la vestimenta en cuartos limpios.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-eb1f5e6 elementor-align-right elementor-widget elementor-widget-button\" data-id=\"eb1f5e6\" data-element_type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/blog.pxsglobal.com\/2022\/08\/09\/como-establecer-los-requerimientos-de-la-vestimenta-en-los-cuartos-limpios\/\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t<span class=\"elementor-button-icon\">\n\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-long-arrow-alt-right\" viewbox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M313.941 216H12c-6.627 0-12 5.373-12 12v56c0 6.627 5.373 12 12 12h301.941v46.059c0 21.382 25.851 32.09 40.971 16.971l86.059-86.059c9.373-9.373 9.373-24.569 0-33.941l-86.059-86.059c-15.119-15.119-40.971-4.411-40.971 16.971V216z\"><\/path><\/svg>\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Read blog<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-4045d2f elementor-widget elementor-widget-spacer\" data-id=\"4045d2f\" data-element_type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-e1caddb\" data-fullscreen-column-settings=\"{&quot;fullscreen&quot;:&quot;&quot;}\" data-id=\"e1caddb\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-b1783fe elementor-section-full_width elementor-section-height-default elementor-section-height-default\" data-id=\"b1783fe\" data-element_type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-inner-column elementor-element elementor-element-d3ef008 elementor-invisible\" data-fullscreen-column-settings=\"{&quot;fullscreen&quot;:&quot;&quot;}\" data-id=\"d3ef008\" data-element_type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;animation&quot;:&quot;fadeIn&quot;,&quot;animation_delay&quot;:400}\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-27c8a2e elementor-widget elementor-widget-litho-heading\" data-id=\"27c8a2e\" data-element_type=\"widget\" data-widget_type=\"litho-heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<span class=\"litho-heading elementor-size-default\"><span class=\"litho-primary-title\">INSTRUCTORES ESPECIALISTAS<\/span><\/span>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-bf9d69d elementor-widget elementor-widget-litho-heading\" data-id=\"bf9d69d\" data-element_type=\"widget\" data-widget_type=\"litho-heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h4 class=\"litho-heading elementor-size-default\"><span class=\"litho-primary-title\">DE ASQ<\/span><\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-5f208de elementor-section-content-top elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"5f208de\" data-element_type=\"section\" id=\"matricular\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-843e98b\" data-fullscreen-column-settings=\"{&quot;fullscreen&quot;:&quot;&quot;}\" data-id=\"843e98b\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-cfc8606 elementor-widget elementor-widget-text-editor\" data-id=\"cfc8606\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><noscript 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Como Auditor Certificado de Dispositivos M\u00e9dicos (CMDA), [&hellip;]<\/p>","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-82465","page","type-page","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v25.3 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>CMDA - PXS<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/pxsglobal.com\/en\/cmda\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"CMDA - PXS\" \/>\n<meta property=\"og:description\" content=\"CURSO DE PREPARACI\u00d3N PARA LA CERTIFICACI\u00d3N DE AUDITOR DE DISPOSITIVOS M\u00c9DICOS DESCRIPCI\u00d3N: \u00a0 \u00bfPOR QU\u00c9 CONVERTIRSE EN UN AUDITOR DE DISPOSITIVOS M\u00c9DICOS CERTIFICADO? 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