醫療器材

科學

EP238-醫療器材合規 vs 持續改善，FDA的自願計畫MDDAP是什麼?

Play Episode Pause Episode

1x

00:00 /

RSS Feed

Share

Link

Embed

<blockquote class="wp-embedded-content" data-secret="FHI6TFkatk"><a href="https://podcast.biomeder.com/episodes/continuous-improvement-us-fda-mddap/">EP238-醫療器材合規 vs 持續改善，FDA的自願計畫MDDAP是什麼?</a></blockquote><iframe sandbox="allow-scripts" security="restricted" src="https://podcast.biomeder.com/episodes/continuous-improvement-us-fda-mddap/embed/#?secret=FHI6TFkatk" width="500" height="350" title="EP238-醫療器材合規 vs 持續改善，FDA的自願計畫MDDAP是什麼? &#8212; 生醫人生旅歷" data-secret="FHI6TFkatk" frameborder="0" marginwidth="0" marginheight="0" scrolling="no" class="wp-embedded-content"></iframe><script> /*! This file is auto-generated */ !function(d,l){"use strict";l.querySelector&&d.addEventListener&&"undefined"!=typeof URL&&(d.wp=d.wp||{},d.wp.receiveEmbedMessage||(d.wp.receiveEmbedMessage=function(e){var t=e.data;if((t||t.secret||t.message||t.value)&&!/[^a-zA-Z0-9]/.test(t.secret)){for(var s,r,n,a=l.querySelectorAll('iframe[data-secret="'+t.secret+'"]'),o=l.querySelectorAll('blockquote[data-secret="'+t.secret+'"]'),c=new RegExp("^https?:$","i"),i=0;i<o.length;i++)o[i].style.display="none";for(i=0;i<a.length;i++)s=a[i],e.source===s.contentWindow&&(s.removeAttribute("style"),"height"===t.message?(1e3<(r=parseInt(t.value,10))?r=1e3:~~r<200&&(r=200),s.height=r):"link"===t.message&&(r=new URL(s.getAttribute("src")),n=new URL(t.value),c.test(n.protocol))&&n.host===r.host&&l.activeElement===s&&(d.top.location.href=t.value))}},d.addEventListener("message",d.wp.receiveEmbedMessage,!1),l.addEventListener("DOMContentLoaded",function(){for(var e,t,s=l.querySelectorAll("iframe.wp-embedded-content"),r=0;r<s.length;r++)(t=(e=s[r]).getAttribute("data-secret"))||(t=Math.random().toString(36).substring(2,12),e.src+="#?secret="+t,e.setAttribute("data-secret",t)),e.contentWindow.postMessage({message:"ready",secret:t},"*")},!1)))}(window,document); //# sourceURL=https://podcast.biomeder.com/wp-includes/js/wp-embed.min.js </script>

MDDAP（Medical Device Discovery Appraisal Program）是 US FDA 在2023年9月正式公佈的自願改進計劃（Voluntary Improvement Program, VIP）。核心與傳統的監管模式不同，從單純的「法規合規（Compliance）」轉向「持續改善(Continuous Improvement)」