| 000 | 00876camuu22002654a 4500 | |
| 001 | 000045207899 | |
| 005 | 20051124131659 | |
| 008 | 040528s2005 flua b 001 0 eng | |
| 010 | ▼a 2004051971 | |
| 020 | ▼a 0849321050 (alk. paper) | |
| 040 | ▼a DLC ▼c DLC ▼d DLC ▼d 211009 | |
| 042 | ▼a pcc | |
| 050 | 0 0 | ▼a R856.6 ▼b .J876 2005 |
| 082 | 0 0 | ▼a 610/.28/4 ▼2 22 |
| 090 | ▼a 610.284 ▼b J96s | |
| 100 | 1 | ▼a Justiniano, Jose M. |
| 245 | 1 0 | ▼a Six Sigma for medical device design / ▼c Jose Justiniano, Venky Gopalaswamy. |
| 260 | ▼a Boca Raton, FL : ▼b CRC Press , ▼c c2005. | |
| 300 | ▼a 133 p. : ▼b ill. ; ▼c 24 cm. | |
| 504 | ▼a Includes bibliographical references and index. | |
| 650 | 0 | ▼a Medical instruments and apparatus ▼x Standards. |
| 650 | 0 | ▼a Six sigma (Quality control standard) |
| 700 | 1 | ▼a Gopalaswamy, Venky. |
| 945 | ▼a KINS |
소장정보
| No. | 소장처 | 청구기호 | 등록번호 | 도서상태 | 반납예정일 | 예약 | 서비스 |
|---|---|---|---|---|---|---|---|
| No. 1 | 소장처 중앙도서관/서고7층/ | 청구기호 610.284 J96s | 등록번호 111340732 (1회 대출) | 도서상태 대출가능 | 반납예정일 | 예약 | 서비스 |
컨텐츠정보
책소개
For designers of medical devices, the FDA and ISO requirements are extremely stringent. Designers and researchers feel pressure from management to quickly develop new devices, while they are simultaneously hampered by strict guidelines. The Six Sigma philosophy has solved this dichotomous paradigm for organizations in other fields, and seeks to do the same for the medical devices field.
Six Sigma for Medical Device Design is the first book to approach the subject for use in the medical device field. Authored by experienced professionals, it provides a how-to guide to implementing such a program while dispelling commonly held myths regarding deployment and adoption. This volume also links the philosophy with the FDA's Design Control regulation, useful for companies that must be compliant as well as for those in the process of implementing a quality system for design control.
For management wishing to launch innovative medical devices as quickly as possible, this text establishes a way to align all levels of the organization to produce a high level of development that is both timely and compliant. It is also an excellent tool for technical and scientific personnel to understand the realities of business and markets and to optimize the product realization process.
Authored by experienced professionals, this book uses real world examples and sample plans to provide a practical how-to guide for implementation. It also links the Six Sigma philosophy with the FDA's Design Control and ISO regulations, useful for companies that must be compliant as well as for those in the process of implementing a quality system for design control. This book is an excellent tool for technical and scientific personnel to understand the realities of business and markets, to comply with stringent quality and safety standards, and to optimize the product realization process.
정보제공 :
목차
Regulation, Business, and Six SigmaDesign Control RoadmapSix-Sigma Roadmap For Product And Process DevelopmentDesign Control and Six-Sigma Roadmap LinkagesMeasuring Design For Six Sigma Effectiveness Leadership's Role in Ensuring Success ConclusionAppendicesGlossary and AcronymsSample Design Control and Six-Sigma Plan for product and process development Further Reading
정보제공 :