ABSTRACT

A 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 experienc

chapter 3|10 pages

Risk Assessment and Risk Management

chapter 4|10 pages

Preventing Recalls during Early Design

chapter 8|14 pages

Preventing Software Design Recalls

chapter 13|12 pages

Role of Management in Preventing Recalls