購物比價找書網找車網
FindBook  
 有 1 項符合

Risk Management for Medical Device Manufacturers: [MD and IVD]

的圖書
Risk Management for Medical Device Manufacturers: [MD and IVD] Risk Management for Medical Device Manufacturers: [MD and IVD]

作者:Simon 
出版社:ASQ Quality Press
出版日期:2022-01-20
語言:英文   規格:平裝 / 258頁 / 22.86 x 15.24 x 1.37 cm / 普通級/ 初版
圖書選購
型式價格供應商所屬目錄
 
$ 3300
博客來 博客來
醫學行政與管理
圖書介紹 - 資料來源:博客來   評分:
圖書名稱:Risk Management for Medical Device Manufacturers: [MD and IVD]

內容簡介

As a quality professional in the medical device industry, you know all too well the importance of a risk management process-and how iterative it can be. Industry regulations and standards-like ISO 14971-help medical device manufacturers define risk management processes, but they don’t make them bulletproof, that is, ensure the efficacy of their products while minimizing future liability. This book can help you build a bulletproof, risk process. You will learn how: Designing product and manufacturing processes controls risks Using consistent language in a holistic, closed-loop risk management system leads to greater efficiency Creating useable and audit-ready risk documents can support verification/validation (V/V) sampling plans Developing labels and instructions can help end-users and patients clearly understand the pertinent risks Creating post-market surveillance (PMS) processes is essential to determine if additional clinical/performance studies are necessary Joe Simon holds an MBA and has been a member of ASQ since 2008. Over his nearly 30-year career, he worked with numerous companies as an employee and a consultant to build or improve complaint analysis, trending, post-market surveillance (PMS), nonconformance (NC), corrective action/preventive action (CAPA), stewardship, and risk management processes.

 

詳細資料

  • ISBN:9781636940137
  • 規格:平裝 / 258頁 / 22.86 x 15.24 x 1.37 cm / 普通級 / 初版
  • 出版地:美國
贊助商廣告
 
 
博客來 - 暢銷排行榜
張忠謀自傳:下冊 一九六四 ── 二〇一八
出版日期:2024-11-29
$ 592 
金石堂 - 暢銷排行榜
失智症照護指南[經典暢銷增訂版]
作者:邱銘章、湯麗玉
出版社:原水文化事業股份有限公司
出版日期:2024-02-02
$ 338 
博客來 - 暢銷排行榜
楞嚴經蠡測【第伍冊】
作者:王薀
出版社:善聞文化創意有限公司
出版日期:2024-09-19
$ 300 
博客來 - 暢銷排行榜
蔡康永的情商課:為你自己活一次
作者:蔡康永
出版社:如何
出版日期:2018-11-01
$ 276 
 
Taaze 讀冊生活 - 新書排行榜
重審耶穌(全新增訂版):一位法庭記者的聖經調查事件簿
作者:李.施特博
出版社:啟示
出版日期:2024-11-21
$ 380 
博客來 - 新書排行榜
楞嚴經蠡測【第伍冊】
作者:王薀
出版社:善聞文化創意有限公司
出版日期:2024-09-19
$ 300 
博客來 - 新書排行榜
滿洲鴉片小隊(06)網路限定版
出版日期:2024-11-20
$ 170 
Taaze 讀冊生活 - 新書排行榜
【京都三部曲3】京都思路 (壽岳章子X澤田重隆攜手經典作,在台發行20周年金典珍藏)
作者:壽岳章子
出版社:馬可孛羅
出版日期:2024-11-07
$ 266 
 

©2024 FindBook.com.tw -  購物比價  找書網  找車網  服務條款  隱私權政策