The second edition of a bestseller, Design Controls for the Medical Device Industry provides a comprehensive review of the latest design control requirements, as well as proven tools and techniques to ensure your company's design control program evolves in accordance with current industry practice. The text assists in the development of an effectiv
Preface. Author Biography. Introduction. Device Classification. Overview of Design Controls. Design and Development Planning. Design Inputs Part I. Design Inputs Part II. Design Outputs. Design Review. Design Verification. Risk Management. Design Validation. Biocompatibility. Design Transfer. Design Change. Design History File. Quality System Inspection Technique. References. Appendices. Index.