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

ReportsnReports add new Market 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” to its store., 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. Medical devices play an important role in the healthcare industry.

Medical device recalls market

Published: April 2012
Price - Single User License: US $ 3500    Corporate User License: US $ 10500

                    

Many technological advances have revolutionized the medical equipment industry. Medical devices include a wide range of products that vary in complexity and application. They range from simple devices, such as tongue depressors and medical thermometers, to complex devices such as artificial hearts. The medical devices industry is a large and rapidly growing field that is often complicated by legal technicalities. Therefore, it is important to maintain regulatory surveillance on medical devices in order to protect public health by evaluating the safety and effectiveness of medical devices. Center for Devices and Radiological Health (CDRH) uses its pre-market review and evaluation programs to ensure the safety and effectiveness of new, high risk and complex devices, and uses its post-market surveillance and assessment methods, scientific research, regulatory enforcement tools and educational programs to maintain the safety and effectiveness of medical devices following approval for use.

According to the US Food and Drug Administration (FDA), there were 4,343 medical device recalls from 2005–2010. The number of medical device recalls per annum increased from 578 in 2005 to 928 in 2010.The main reasons for these recalls were problems with device design and process control, which includes developing, conducting, controlling and monitoring production processes to ensure that a device conforms to its specifications; concerns with software design, component design and employee errors; the incorrect labeling of medical devices and the mistaken use of materials and components; as well as medical devices that pose a risk to patient health, devices that violate law, products with sterility failure and maintenance problems, and product repairs and contamination.

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.
• In-depth analysis of the top 10 recall firms in the US from 2005–2010, by year and by recall class.
• The regulatory framework for medical devices in the following seven countries: the US, the UK, Germany, France, Spain, Italy and Japan.

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.
• Reinforce quality and manufacturing strategies so as to be complaint with the current regulation requirements.
• Develop key strategic initiatives by understanding the key focus areas of the medical device recalls market.
• Understand the regulatory frameworks for medical devices in the following countries: the US, the UK, Germany, France, Spain, Italy and Japan.

Source:http://www.reportsnreports.com/reports/155952-regulatory-intelligence-on-medical-device-recalls-ineffective-process-control-defects-in-design-of-device-software-or-other-components-are-the-major-reasons-for-recall.html

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Patient Monitoring Devices Market to 2017 - Increasing Use of Wireless Remote Patient Monitoring to be the Key Technology Trend

GBI Research’s report, “Global Patient Monitoring Devices Market to 2017 - Increasing Use of Wireless Remote Patient Monitoring to be the Key Technology Trend” shows how rising prevalence of chronic diseases, the growing elderly population and advances in wireless and sensors technologies are driving the market globally. The report provides key data, information and analysis on the global patient monitoring devices market, covering the market landscape, competitive landscape and market trends relating to seven patient monitoring devices market categories: remote patient monitoring devices, micro-electro mechanical systems, patient monitoring accessories, non-invasive blood pressure monitors, multiparameter patient monitoring devices, neonatal monitors and fetal monitors. 

Reasons to Buy

• Develop business strategies by understanding the trends and developments that are driving the patient monitoring devices market.
• Design and develop your product development, marketing and sales strategies.
• Capitalize on M&A opportunities by identifying key companies with the most innovative pipeline.
• Develop market entry and market expansion strategies.
• Identify the key companies that are best positioned to take advantage of emerging market opportunities.
• Exploit in-licensing and out-licensing opportunities by identifying the products most likely to ensure a robust return.
• Identify, understand and capitalize on the next big thing in the patient monitoring devices market landscape
• Make more informed business decisions from the insightful and in-depth analysis of the patient monitoring devices market and the factors shaping it.

Wireless Remote Patient Monitoring Device Market

Published: March 2012
Price: Single User License: US$ 3500          Corporate User License: US$ 10500 





The report Provides comprehensive information on the key trends affecting these categories, and key analytical content on the market dynamics, the report also reviews the competitive landscape and gives a detailed analysis of the pipeline products in each category. Details of important merger and acquisition deals that have taken place in the patient monitoring devices market are also reviewed. This report is built using data and information sourced from proprietary databases, primary and secondary research and in-house analysis by GBI Research’s team of industry experts.

Scope

• Key geographies: the US, Canada, the UK, Germany, France, Italy, Spain, Japan, China, India, Australia, and Brazil.
• Market size for seven patient monitoring devices market categories: remote patient monitoring devices, micro-electro mechanical systems, patient monitoring accessories, non-invasive blood pressure monitors, multiparameter patient monitoring devices, neonatal monitors and fetal monitors.
• Annualized market revenues data for 2003–2010, and forecasts for 2010–2017.
• Qualitative analysis of key market trends, market drivers, and restraints by each category within the patient monitoring devices market.
• The report also covers information on the leading companies currently operating in the market, the competitive landscape, and the leading technologies.
• Key players include Philips Healthcare, GE Healthcare, Omron Healthcare Co.,

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