{"id":104,"date":"2019-10-16T11:35:31","date_gmt":"2019-10-16T11:35:31","guid":{"rendered":"http:\/\/www.globalrestructuringadvisors.com\/?page_id=104"},"modified":"2022-02-17T15:02:43","modified_gmt":"2022-02-17T15:02:43","slug":"regulatory","status":"publish","type":"page","link":"https:\/\/www.globalrestructuringadvisors.com\/?page_id=104","title":{"rendered":"Regulatory"},"content":{"rendered":"<p><div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-1 nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-margin-top:-60px;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-0 fusion_builder_column_1_1 1_1 fusion-one-full fusion-column-first fusion-column-last\" style=\"--awb-bg-size:cover;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-column-wrapper-legacy\">\n<div class=\"fusion-slider-revolution rev_slider_wrapper\">\t\t\t<!-- START Regulatory REVOLUTION SLIDER 6.7.9 --><p class=\"rs-p-wp-fix\"><\/p>\n\t\t\t<rs-module-wrap id=\"rev_slider_14_1_wrapper\" data-source=\"gallery\" style=\"visibility:hidden;background:transparent;padding:0;margin:0px auto;margin-top:0;margin-bottom:0;\">\n\t\t\t\t<rs-module id=\"rev_slider_14_1\" style=\"\" data-version=\"6.7.9\">\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-29\" data-title=\"Slide\" data-anim=\"ms:1000;r:0;\" data-in=\"o:0;\" data-out=\"a:false;\">\n\t\t\t\t\t\t\t<img decoding=\"async\" src=\"\/\/www.globalrestructuringadvisors.com\/wp-content\/plugins\/revslider\/sr6\/assets\/assets\/dummy.png\" alt=\"Slide\" title=\"Regulatory\" class=\"rev-slidebg tp-rs-img rs-lazyload\" data-lazyload=\"\/\/www.globalrestructuringadvisors.com\/wp-content\/plugins\/revslider\/sr6\/assets\/assets\/transparent.png\" data-no-retina>\n<!--\n\t\t\t\t\t\t\t--><rs-layer\n\t\t\t\t\t\t\t\tid=\"slider-14-slide-29-layer-1\" \n\t\t\t\t\t\t\t\tdata-type=\"text\"\n\t\t\t\t\t\t\t\tdata-color=\"#000000\"\n\t\t\t\t\t\t\t\tdata-rsp_ch=\"on\"\n\t\t\t\t\t\t\t\tdata-xy=\"x:1px;y:54px;\"\n\t\t\t\t\t\t\t\tdata-text=\"w:normal;s:81;l:250;fw:200;a:center;\"\n\t\t\t\t\t\t\t\tdata-dim=\"w:1064px;\"\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:9;background-color:rgba(255,255,255,0.65);font-family:'Raleway';\"\n\t\t\t\t\t\t\t>Regulatory \n\t\t\t\t\t\t\t<\/rs-layer><!--\n\n\t\t\t\t\t\t\t--><rs-layer\n\t\t\t\t\t\t\t\tid=\"slider-14-slide-29-layer-2\" \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:-6px;y:-95px;\"\n\t\t\t\t\t\t\t\tdata-text=\"w:normal;\"\n\t\t\t\t\t\t\t\tdata-dim=\"w:1920px;h:1306px;\"\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:8;\"\n\t\t\t\t\t\t\t><img decoding=\"async\" src=\"\/\/www.globalrestructuringadvisors.com\/wp-content\/plugins\/revslider\/sr6\/assets\/assets\/dummy.png\" alt=\"\" class=\"disable-lazyload tp-rs-img rs-lazyload\" width=\"1920\" height=\"1306\" data-lazyload=\"\/\/www.globalrestructuringadvisors.com\/wp-content\/uploads\/2019\/11\/galleon-ship-photo-under-the-cloudy-sky-1050656.jpg\" data-no-retina> \n\t\t\t\t\t\t\t<\/rs-layer><!--\n-->\t\t\t\t\t<\/rs-slide>\n\t\t\t\t\t<\/rs-slides>\n\t\t\t\t<\/rs-module>\n\t\t\t\t<script>\n\t\t\t\t\tsetREVStartSize({c: 'rev_slider_14_1',rl:[1240,1024,778,480],el:[650],gw:[1800],gh:[650],type:'standard',justify:'',layout:'fullwidth',mh:\"0\"});if (window.RS_MODULES!==undefined && window.RS_MODULES.modules!==undefined && window.RS_MODULES.modules[\"revslider141\"]!==undefined) {window.RS_MODULES.modules[\"revslider141\"].once = false;window.revapi14 = 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><div class=\"fusion-clearfix\"><\/div><\/div><\/div><\/div><\/div><div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-2 nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-1 fusion_builder_column_1_1 1_1 fusion-one-full fusion-column-first fusion-column-last\" style=\"--awb-bg-size:cover;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-column-wrapper-legacy\"><div class=\"fusion-sep-clear\"><\/div><div class=\"fusion-separator fusion-full-width-sep\" style=\"margin-left: auto;margin-right: auto;margin-top:2%;width:100%;\"><\/div><div class=\"fusion-sep-clear\"><\/div><div class=\"fusion-text fusion-text-1\"><h3>The field of medical-healthcare products not only comprises an extremely broad, but also an extremely demanding product spectrum. For good reason, the international quality standards are at a very high level, which can only be achieved with appropriate controls and regulation mechanisms. Regulatory hurdles therefore have a decisive influence on the success of the companies and increasingly represent an obstacle to innovation and growth. Young companies in particular find it difficult to successfully launch their products on the market with the necessary stamina in view of the fulfillement of regulatory-compliance and reimbursement issues.<\/h3>\n<h3>Legal requirements are complex and vary from region to region.<\/h3>\n<\/div><div class=\"fusion-text fusion-text-2\"><p><span style=\"color: #ffffff;\">0<\/span><\/p>\n<\/div><div class=\"fusion-text fusion-text-3\"><h2 style=\"text-align: center;\"><strong>Overview of regional services<\/strong><\/h2>\n<\/div><div class=\"fusion-text fusion-text-4\"><p><span style=\"color: #ffffff;\">0<\/span><\/p>\n<\/div><div class=\"fusion-content-boxes content-boxes columns row fusion-columns-4 fusion-columns-total-4 fusion-content-boxes-1 content-boxes-icon-with-title content-left\" style=\"--awb-title-color:#000000;--awb-hover-accent-color:#65bc7b;--awb-circle-hover-accent-color:#65bc7b;\" data-animationOffset=\"top-into-view\"><div style=\"--awb-backgroundcolor:rgba(255,255,255,0);\" class=\"fusion-column content-box-column content-box-column content-box-column-1 col-lg-3 col-md-3 col-sm-3 fusion-content-box-hover content-box-column-first-in-row\"><div class=\"col content-box-wrapper content-wrapper link-area-link-icon icon-hover-animation-fade\" data-animationOffset=\"top-into-view\"><div class=\"heading icon-left\"><h1 class=\"content-box-heading fusion-responsive-typography-calculated\" style=\"--h1_typography-font-size:18px;--fontSize:18;line-height:1.4;\">USA<\/h1><\/div><div class=\"fusion-clearfix\"><\/div><div class=\"content-container\">\n<h4 style=\"text-align: left;\">US FDA 510(k)<\/h4>\n<h4 style=\"text-align: left;\">FDA QSR (21 CFR 820)<\/h4>\n<h4 style=\"text-align: left;\">US FDA Medical Device Classification<\/h4>\n<h4 style=\"text-align: left;\">Medical Device Single Audit (MDSAP)<\/h4>\n<h4 style=\"text-align: left;\">US FDA Official Correspondent<\/h4>\n<h4 style=\"text-align: left;\">FDA eMDR<\/h4>\n<h4 style=\"text-align: left;\">Medical Device UDI<\/h4>\n<h4 style=\"text-align: left;\">Medical Device CFG<\/h4>\n<h4 style=\"text-align: left;\">QMS Compliance<\/h4>\n<h4 style=\"text-align: left;\">FDA IVD<\/h4>\n<h4 style=\"text-align: left;\">Telehealth &amp; Mobile Apps<\/h4>\n<h4 style=\"text-align: left;\">US FDA Pre-Sub (Q-Sub)<\/h4>\n<h4 style=\"text-align: left;\">ISO 14971<\/h4>\n<h4 style=\"text-align: left;\">ISO 13485<\/h4>\n<h4 style=\"text-align: left;\">US FDA Form 483<\/h4>\n<h4 style=\"text-align: left;\">QA- &amp; QR Services<\/h4>\n<h4 style=\"text-align: left;\">US FDA Agent Representation<\/h4>\n<\/div><\/div><\/div><div style=\"--awb-backgroundcolor:rgba(255,255,255,0);\" class=\"fusion-column content-box-column content-box-column content-box-column-2 col-lg-3 col-md-3 col-sm-3 fusion-content-box-hover \"><div class=\"col content-box-wrapper content-wrapper link-area-link-icon icon-hover-animation-fade\" data-animationOffset=\"top-into-view\"><div class=\"heading icon-left\"><h1 class=\"content-box-heading fusion-responsive-typography-calculated\" style=\"--h1_typography-font-size:18px;--fontSize:18;line-height:1.4;\">EUROPE<\/h1><\/div><div class=\"fusion-clearfix\"><\/div><div class=\"content-container\">\n<h4 class=\"card-title\">EU MDR<\/h4>\n<h4 class=\"card-title\">EU Medical Devices Regulation 2017,745 (MDR)<\/h4>\n<h4 class=\"card-title\">MEDDEV 2.7.1 rev 4 and Clinical Evaluation Reports (CER)<\/h4>\n<h4 class=\"card-title\">GCP and ISO 14155 Compliance<\/h4>\n<h4 class=\"card-title\">ISO 13485:2016<\/h4>\n<h4 class=\"card-title\">Medical Device Vigilance and Incidence Reporting<\/h4>\n<h4 class=\"card-title\">European CE Marking for In Vitro Diagnostics<\/h4>\n<h4 class=\"card-title\">QMS Compliance<\/h4>\n<h4 class=\"card-title\">CE Marking for Medical Devices<\/h4>\n<h4 class=\"card-title\">Telehealth &amp; Mobile Apps<\/h4>\n<h4 class=\"card-title\">PMCF<\/h4>\n<h4 class=\"card-title\">Clinical Trial Data Management<\/h4>\n<h4 class=\"card-title\">QA &amp; RA Services<\/h4>\n<h4 class=\"card-title\">European Authorized Representative<\/h4>\n<h4>iVDR 2017.746<\/h4>\n<\/div><\/div><\/div><div style=\"--awb-backgroundcolor:rgba(255,255,255,0);\" class=\"fusion-column content-box-column content-box-column content-box-column-3 col-lg-3 col-md-3 col-sm-3 fusion-content-box-hover \"><div class=\"col content-box-wrapper content-wrapper link-area-link-icon icon-hover-animation-fade\" data-animationOffset=\"top-into-view\"><div class=\"heading icon-left\"><h1 class=\"content-box-heading fusion-responsive-typography-calculated\" style=\"--h1_typography-font-size:18px;--fontSize:18;line-height:1.4;\">ASIA<\/h1><\/div><div class=\"fusion-clearfix\"><\/div><div class=\"content-container\">\n<h4>PMDA Medical Device Registration<\/h4>\n<h4>JMDN Consulting<\/h4>\n<h4>JMDN Code Research<\/h4>\n<h4>Quality Management System Compliance with Japan Ordinance 169<\/h4>\n<h4>MDSAP<\/h4>\n<h4>PMDA Registration for In Vitro Diagnostics (IVD)<\/h4>\n<h4>Foreign Manufacturer Registration<\/h4>\n<h4>Telehealth &amp; Mobile Apps<\/h4>\n<h4>ISO 14971 Risk Management<\/h4>\n<h4>QMS Audits<\/h4>\n<h4>ISO 13485 &amp; FDA QSR Audits<\/h4>\n<h4>QA &amp; RA Services<\/h4>\n<h4 style=\"text-align: left;\"><\/h4>\n<\/div><\/div><\/div><div style=\"--awb-backgroundcolor:rgba(255,255,255,0);\" class=\"fusion-column content-box-column content-box-column content-box-column-4 col-lg-3 col-md-3 col-sm-3 fusion-content-box-hover content-box-column-last content-box-column-last-in-row\"><div class=\"col content-box-wrapper content-wrapper link-area-link-icon icon-hover-animation-fade\" data-animationOffset=\"top-into-view\"><div class=\"heading icon-left\"><h1 class=\"content-box-heading fusion-responsive-typography-calculated\" style=\"--h1_typography-font-size:18px;--fontSize:18;line-height:1.4;\">LATAM<\/h1><\/div><div class=\"fusion-clearfix\"><\/div><div class=\"content-container\">\n<h4>ANVISA Medical Device Registration and Approval in Brasil<\/h4>\n<h4>Brazil GMP Quality System Compliance (BGMP)<\/h4>\n<h4>ANVISA Registration Holder Service<\/h4>\n<h4>MDSAP<\/h4>\n<h4>Medical Device Vigilance Reporting for ANVISA<\/h4>\n<h4>Brazil INMETRO Certification<\/h4>\n<h4>QA &amp; RA Outsourcing<\/h4>\n<h4>COFEPRIS Medical Device and IVD Registration and Approval in Mexico<\/h4>\n<h4>Mexico Registration Holder<\/h4>\n<h4>Medical Device Vigilance Reporting in Mexico<\/h4>\n<h4>Classification of Medical Devices in Mexico<\/h4>\n<h4>INVIMA Medical Device Registration and Approval in Colombia<\/h4>\n<h4>Colombia Legal Representation for Medical Device Companies<\/h4>\n<\/div><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div><div class=\"fusion-text fusion-text-5\"><h3>GRA offers comprehensive knowledge and many years of experience in the most important markets for medical products worldwide. The expertise of the consulting team enables you to overcome the hurdles of the respective region.<\/h3>\n<\/div><div class=\"fusion-text fusion-text-6\"><p><span style=\"color: #ffffff;\">0<\/span><\/p>\n<\/div><div class=\"fusion-text fusion-text-7\"><p><span style=\"color: #ffffff;\">0<\/span><\/p>\n<\/div><div class=\"fusion-text fusion-text-8\"><p><span style=\"color: #ffffff;\">0<\/span><\/p>\n<\/div><div class=\"fusion-text fusion-text-9\"><p style=\"text-align: center;\"><strong>We take a holistic and <span style=\"color: #333333;\">integrated <\/span>view of what is happening in lifesciences <\/strong><strong>today <\/strong><strong>and help your company to manage the future.<\/strong><\/p>\n<\/div><div class=\"fusion-clearfix\"><\/div><\/div><\/div><\/div><\/div><\/p>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-104","page","type-page","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - 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