Practical Design Control Implementation for Medical Devices
Langue : Anglais
Auteurs : Justiniano Jose, Gopalaswamy Venky
Bringing together the concepts of design control and reliability engineering, this book is a must for medical device manufacturers. It helps them meet the challenge of designing and developing products that meet or exceed customer expectations and also meet regulatory requirements. Part One covers motivation for design control and validation, design control requirements, process validation and design transfer, quality system for design control, and measuring design control program effectiveness. Part Two discusses risk analysis and FMEA, designing-in reliability, reliability and design verification, and reliability and design validation.
PART ONE Practical Design Control Implementation, PART TWO Medical Device Reliability, Conclusion, Acronyms and Definitions, References
Academic and Professional Practice & Development
Justiniano, Jose; Gopalaswamy, Venky
Date de parution : 09-2019
17.8x25.4 cm
Date de parution : 02-2003
Ouvrage de 232 p.
18x25 cm
Thèmes de Practical Design Control Implementation for Medical Devices :
Mots-clés :
Design FMEA; Process FMEA; Medical Device; Design Control Requirements; Reliable Medical Devices; Design Control; CFR; Quality System Regulation; Medical Device Design; FDA CDRH; CDRH; Firm’s Quality Systems; Medical Device Industry; Design Verification; Design Validation; Weibull Plot; Design Transfer; Design Control Guidelines; Safety Factors; Reliability Plan; Design Inputs; Initial Production Units; Design Output; Luer Lock; Design Control Guidance
© 2024 LAVOISIER S.A.S.
