Guidelines for Failure Modes and Effects Analysis for Medical Devices

個数：

Guidelines for Failure Modes and Effects Analysis for Medical Devices

  • 在庫がございません。海外の書籍取次会社を通じて出版社等からお取り寄せいたします。
    通常6～9週間ほどで発送の見込みですが、商品によってはさらに時間がかかることもございます。
    【重要ご説明事項】
    1. 納期遅延や、ご入手不能となる場合がございます。
    2. 複数冊ご注文の場合、分割発送となる場合がございます。
    3. 美品のご指定は承りかねます。
  • 【入荷遅延について】
    世界情勢の影響により、海外からお取り寄せとなる洋書・洋古書の入荷が、表示している標準的な納期よりも遅延する場合がございます。
    おそれいりますが、あらかじめご了承くださいますようお願い申し上げます。
  • ◆画像の表紙や帯等は実物とは異なる場合があります。
  • ◆ウェブストアでの洋書販売価格は、弊社店舗等での販売価格とは異なります。
    また、洋書販売価格は、ご注文確定時点での日本円価格となります。
    ご注文確定後に、同じ洋書の販売価格が変動しても、それは反映されません。
  • 製本 Paperback:紙装版/ペーパーバック版／ページ数 190 p.
  • 言語 ENG
  • 商品コード 9780849319105
  • DDC分類 681.761

Full Description

Challenged by stringent regulations, vigorous competition, and liability lawsuits, medical device manufactures must develop safe, reliable, and cost-effective products, and managing and reducing risk is a vital element of reaching that goal. A practical guide to achieving corporate consistency while dramatically cutting the time required for studies, Guidelines for Failure Modes and Effects Analysis for Medical Devices focuses on Failure Modes and Effects Analysis (FMEA) and its application throughout the life cycle of a medical device. It outlines the major U.S. and E.U. standards and regulations and provides a detailed yet easy-to-read overview of risk management and risk analysis methodologies, common FMEA pitfalls, and FMECA-Failure Mode, Effects, and Criticality Analysis.

Discover how the FMEA methodology can help your company achieve a more cost-effective manufacturing process by improving the quality and reliability of your products. This new FMEA manual from the experts at Dyadem is the ultimate resource for you and your colleagues to learn more about Failure Modes and Effects Analysis and then teach others at your facility. This comprehensive manual is sure to become a standard reference for engineering professionals.

Contents

Glossary, CHAPTER 1 - Introduction, CHAPTER 2 - Regulations Standards Governing Medical Device Manufacturing, CHAPTER 3 - Risk Management of Medical Devices, CHAPTER 4 - Risk Analysis Methodologies, CHAPTER 5 - Overview of FMEA, CHAPTER 6 - FMEA Procedures, CHAPTER 7 - FMEA Team, CHAPTER 8 - Pitfalls with FMEA, CHAPTER 9 - Common Tools Used with FMEA, CHAPTER 10 - Product Life Cycle FMEA, CHAPTER 11 - Product/Design FMEA, CHAPTER 12 - Process FMEA, CHAPTER 13 - Application FMEA, CHAPTER 14 - Service FMEA, CHAPTER 15 - Post FMEA Study, CHAPTER 16 - Control Plans, CHAPTER 17 - Overview of Failure Mode, Effects, and Criticality Analysis (FMECA), References