Description
Book SynopsisA critical and often overlooked aspect of preventing medical device recalls is the ability to implement systems thinking. Although systems thinking won't prevent every mistake, it remains one of the most effective tools for evaluating hidden risks and discovering robust solutions for eliminating those risks.
Based on the author's extensive experience in the medical device, aerospace, and manufacturing engineering industries, Preventing Medical Device Recalls presents a detailed structure for systems thinking that can help to prevent costly device recalls. Based on Dr. W. Edwards Deming's System of Profound Knowledge, this structure can help medical device designers and manufacturers exceed their customers' expectations for quality and safety.
This book is among the first to demonstrate how to control safety risksfrom specifications all the way through to safely retiring products without harm to the environment. Supplying an accessible overview of medic
Table of Contents
Overview of Medical Device Requirements. Preventing Recalls during Specification Writing. Risk Assessment and Management. Preventing Recalls during Design and Development. Preventing Recalls during Production. Preventing Software Design Recalls. Preventing Supplier Quality Defects. Preventing Recalls during Verification and Validation. Validation Testing to Discover Design and Manufacturing Errors. Preventing Recalls during Field Monitoring. Planning for Potential Recalls to Maximize Efficiency in the Event of a Recall. Role of Management in Preventing Recalls. Appendix.
