Six Sigma for Medical Device Design is the first book to apply Six Sigma principles to the design of medical devices. Authored by experienced professionals, it uses real world examples and sample plans to provide a practical how-to guide for implementation. This volume 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.
Autorentext
Jose Justiniano (Mason, Ohio, USA) (Author), Venky Gopalaswamy (Author)
Zusammenfassung
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
Inhalt
Regulation, Business, and Six Sigma. Design Control Roadmap. Six-Sigma Roadmap For Product And Process Development. Design Control and Six-Sigma Roadmap Linkages. Measuring Design For Six Sigma Effectiveness. Leadership's Role in Ensuring Success. Conclusion. Appendices.