Ineffective Process Control, Defects in Design of Device, Software or Other Components are the Major Reasons for Recall”, provides an in-depth analysis on medical device recalls in the US. The report analyzes the number of medical device recalls in the US by year, recall class, therapeutic area and root cause from 2005–2010. The report includes an in-depth analysis on medical device recalls by the top 10 recall firms, with the number of device recalls by year and by recall class. The report presents information on medical device regulatory systems, with emphasis on regulatory intelligence in the following seven countries: the US, the UK, Germany, France, Spain, Italy and Japan. The medical equipment approval process, device classification, conformity assessment process and post-market surveillance are explained in the report.