1.0CACTUShttps://cactusglobal.com/krrich600338<blockquote class="wp-embedded-content" data-secret="zyd0aAttpY"><a href="https://cactusglobal.com/kr/service/medical-communications/medical-device-solutions/">의료기기 솔루션</a></blockquote><iframe sandbox="allow-scripts" security="restricted" src="https://cactusglobal.com/kr/service/medical-communications/medical-device-solutions/embed/#?secret=zyd0aAttpY" width="600" height="338" title="“의료기기 솔루션” — CACTUS" data-secret="zyd0aAttpY" frameborder="0" marginwidth="0" marginheight="0" scrolling="no" class="wp-embedded-content"></iframe><script type="text/javascript"> /*! This file is auto-generated */ !function(c,d){"use strict";var e=!1,o=!1;if(d.querySelector)if(c.addEventListener)e=!0;if(c.wp=c.wp||{},c.wp.receiveEmbedMessage);else if(c.wp.receiveEmbedMessage=function(e){var t=e.data;if(!t);else if(!(t.secret||t.message||t.value));else if(/[^a-zA-Z0-9]/.test(t.secret));else{for(var r,s,a,i=d.querySelectorAll('iframe[data-secret="'+t.secret+'"]'),n=d.querySelectorAll('blockquote[data-secret="'+t.secret+'"]'),o=new RegExp("^https?:$","i"),l=0;l<n.length;l++)n[l].style.display="none";for(l=0;l<i.length;l++)if(r=i[l],e.source!==r.contentWindow);else{if(r.removeAttribute("style"),"height"===t.message){if(1e3<(s=parseInt(t.value,10)))s=1e3;else if(~~s<200)s=200;r.height=s}if("link"===t.message)if(s=d.createElement("a"),a=d.createElement("a"),s.href=r.getAttribute("src"),a.href=t.value,!o.test(a.protocol));else if(a.host===s.host)if(d.activeElement===r)c.top.location.href=t.value}}},e)c.addEventListener("message",c.wp.receiveEmbedMessage,!1),d.addEventListener("DOMContentLoaded",t,!1),c.addEventListener("load",t,!1);function t(){if(o);else{o=!0;for(var e,t,r,s=-1!==navigator.appVersion.indexOf("MSIE 10"),a=!!navigator.userAgent.match(/Trident.*rv:11\./),i=d.querySelectorAll("iframe.wp-embedded-content"),n=0;n<i.length;n++){if(!(r=(t=i[n]).getAttribute("data-secret")))r=Math.random().toString(36).substr(2,10),t.src+="#?secret="+r,t.setAttribute("data-secret",r);if(s||a)(e=t.cloneNode(!0)).removeAttribute("security"),t.parentNode.replaceChild(e,t);t.contentWindow.postMessage({message:"ready",secret:r},"*")}}}}(window,document); </script> https://cactusglobal.com/kr/wp-content/uploads/2020/02/medical-device-solutions-banner-3.jpg974668Cactus Life Sciences helps medical device companies access and stay compliant in the European and Chinese markets. We support every aspect of the Clinical Evaluation Report (CER) process. Our writing and reviewing pool has extensive experience in multiple areas of clinical evaluation across a vast array of therapeutic areas. What we offer: New Clinical Evaluation Report (MEDDEV 2.7.1 REV 4 and EU MDR), Update of an existing Clinical Evaluation Report (under new EU MDR guidelines), Clinical Evaluation Plan (CEP) development, Post Market Surveillance (PMS) + Report and Periodic Safety Update Report (PSUR), MDR Requirements, Summary of safety and clinical performance (SSCP), Post Market Clinical Follow-up (PMCF) Plan, Benefit Risk Analysis (BRA), CER Remediation Support/Notified Body Response, Gap Analysis of existing documents for EU MDR compliance, and CER format/QC support.