發表文章

[關於EU MDR之雜談]:MDR會對代工廠造成衝擊嗎?

最近收看了一場由Notified Body所主持的線上研討會讓我頗有感觸地,因為這場研討會描述到隨著即將上路的EU MDR,EU parliament預測可能會有15%的醫療器材產品退出歐洲市場;而Notified Body則是更悲觀地預測為25%.我們都瞭解MDR會對於醫療器材製造商造成不小的衝擊,那對於代工廠呢?由於整體歐洲市場需求不變,有產品退出理應會有新產品或是既有的大廠取代之,因此代工廠的代工需求/訂單數量應該不會受到影響吧?對吧?

[2020 US FDA Regulatory Education for Industry (REdI) Annual Conference]

[Webinar 分享] COMPANIES DEVELOPING AND COMMERCIALIZING SOFTWARE AS MEDICAL DEVICES

[ EU MDR 對於代表性產品(representative device)的規範 ]

[FDA webinar series]: "Special 510(k) Program Pilot"

[FDA webinar series]: "Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications (510(k)) with Different Technological Characteristics"

[ Design History File 系列探討 ]:Design History File (DHF) 的定義以及在品質系統中所扮演的角色!

[ EU MDR 深入探討: CER, PMCF 和 PMS 為何物? (上) ]

[ EU Medical Device Regulation (MDR) 的基本須知 ]

[ Abbreviated 510(k) ??? ]