Reliable design of medical devices. (2006)

• Record Type: Book
• Further Information: Note: Richard Fries.
• Other Names: Fries, Richard C
• Contents: BASICS OF RELIABILITY; Reliability; The Concept of Failure; REGULATIONS AND STANDARDS; The Food and Drug Administration; The Medical Device Directives; Quality System Regulation; Domestic Standards; International Standards; SPECIFYING THE PRODUCT; The Medical Device as an Entity; Defining the Device; Requirements Engineering; Safety and Risk Management; Liability; Intellectual Property; DESIGNING THE PRODUCT; Six Sigma and Product Design; Hardware Design; Software Design; Software Coding; Establishing and Using Metrics; Human Factors; TESTING AND DATA ANALYSIS; The Basis and Types of Testing; Hardware Verification and Validation; Software Verification and Validation; Analysis of Test Results; THE MANUFACTURING AND MAINTENANCE PROCESSES; GMPs and Manufacturing; Configuration Management; Analysis of Field Data; APPENDICES; Appendix 1: Chi Square Table; Appendix 2: Percent Rank Tables; Appendix 3: Common Failure Modes; Appendix 4: Glossary; INDEX
• Edition: 2nd ed
• Publisher Details: Boca Raton : CRC/Taylor & Francis
• Publication Date: 2006
• Extent: 1 online resource (xxvi, 475 pages), illustrations
• Subjects: 681/.761; Medical instruments and apparatus -- Reliability; Medical instruments and apparatus -- Design and construction; Medical instruments and apparatus -- Quality control; Medical instruments and apparatus -- Standards; Equipment Design -- methods; Equipment and Supplies -- standards; Equipment Design -- standards; Equipment Failure; Software Design; MEDICAL -- Allied Health Services -- Medical Technology; Medical instruments and apparatus -- Design and construction; Medical instruments and apparatus -- Quality control; Medical instruments and apparatus -- Reliability; Medical instruments and apparatus -- Standards; Electronic books
• Languages: English
• ISBNs: 1420027948; 9781420027945
• Related ISBNs: 0824723759
• Notes: Note: Includes bibliographical references and index.; Note: Print version record.
• Access Rights: Legal Deposit; Only available on premises controlled by the deposit library and to one user at any one time; The Legal Deposit Libraries (Non-Print Works) Regulations (UK).
• Access Usage: Restricted: Printing from this resource is governed by The Legal Deposit Libraries (Non-Print Works) Regulations (UK) and UK copyright law currently in force.