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Regulatory Intelligence on Medical Device Recalls -
Ineffective Process Control, Defects in Design of Device,
Software or Other Components are the Major Reasons for
Recall




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Summary

GBI Research report, “Regulatory Intelligence on Medical Device Recalls - 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.


Scope
- The basic concepts of medical device recalls, such as device classification and the
device recall process by the FDA.
- Medical device recalls in the US by year, recall class, number of recalls in different
therapeutic areas and root cause.

Reasons to buy

- Analyze the number of recalls by year from 2005–2010.
- Analyze the key reasons for recalls, along with the therapy areas and class of
recalled devices, in order to strengthen the areas which may lead to quality defects
in a company’s product portfolio.


Table of contents:

1.1 List of Tables 5
1.2 List of Figures 6
2 Regulatory Intelligence on Medical Device Recalls - Introduction 8
2.1 GBI Report Guidance 9
3 Regulatory Intelligence on Medical Device Recalls - Overview 10
3.1 FDA Medical Device Recall Process 11
4 Analysis of Medical Device Recalls from 2005–2010 12
4.1 Number of Recalls by Year 12
4.2 Number of Recalls by Class 13
4.3 Number of Recalls by Therapeutic Area 15
4.4 Number of Recalls by Root Cause 16
4.5 Number of Recalls by Top Ten Recall Firms 17
4.6 Analysis of Top 10 Recall Companies’ Medical Device Recalls 19
4.6.1 Stryker 19
4.6.2 Abbott 21
4.6.3 Medtronic 23
4.6.4 Siemens 25
4.6.5 GE 28
4.6.6 Philips 30
4.6.7 Boston Scientific 32
4.6.8 Baxter 36
4.6.9 Zimmer 38
4.6.10 Biomet 40
5 Global Harmonization Task Force 43
List of Figures

List of Tables are also include.



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