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Understanding Medical Devices: an Introduction to the Medical Device Industry
Understanding Medical Devices: An introduction to the medical device industry throws light on the meaning of medical devices and the effects that the global trends have on their usage and demand. It informs about the research that is aimed at improving the medical devices and the various solutions to overcome the barriers in the choosing of medical devices. The book makes the readers understand the various guidelines for medical device donations and throws light on the importance of public health in this sector. Also discussed in the book are the examples of various medical devices, the essential principles of safety and performance, the use of standards by the regulatory bodies, the various phases of medical device development, the responsible entity for the medical devices and the way the medical device industry has globalized.
Clinical Evaluations for Medical Devices
Being a medical device manufacturer involves more than just manufacturing of the device itself. It is also the manufacturers responsibility to ensure adequate research is done on the device so that it can be safely used. Clinical evidence is often collected throughout the entire life cycle of a medical device and is often an ongoing process. The process starts during the design and development of the device to show safety and efficacy and is often updated even after the device is on the market. This evidence is often compiled in a Clinical Evaluation Report and presents itself a chapter of the device technical file. As the medical industry continues to evolve, so does the complexity of clinical data needed during the regulatory approval process. This volume provides an introduction into the basic concepts of clinical evaluation report writing. Important concepts such as how to conduct a literature review, claiming equivalence and when to update your clinical reports are covered.
A Beginners Road Map to the Medical Device Industry
It is estimated that there are over 10 000 different medical devices available on the market today. These devices have become an integral part of health care and a vital component of the various activities carried out by health-care providers to treat people with varying medical conditions all around the world. Regulatory requirements for such devices differ from country to country all around the world which in turn make it difficult for manufacturers to obtain all round market approval for their products. While market approval from regulatory authorities can easily be obtained if a manufacturer can prove the device meets national regulatory guidelines; differences in regulatory requirements...
Essential Principles of Safety and Effectiveness for Medical Devices
The medical device sector is growing fast. Every day new technology which is both complex and smart are being added to the industry. Ensuring safe and effective use of medical devices for patients and users of the device itself is a crucial responsibility for manufacturers. When designing and manufacturing medical devices, safety, and efficacy should be of utmost importance. A manufacturer should never compromise on the clinical safety requirements of its users, patients or any other persons involved. Generally, the design of a medical device is regulated by the essential principles (EP) of safety and performance. What this means is that if a device is designed to relieve pain, the manufactu...
Encyclopedia of Environmental Science (Set of 7 Volumes)
To save the natural environment, a good and effective understanding of environmental science is needed. The 7-Volume Encyclopedia of Environmental Science includes comprehensive information related to environmental science which features cutting-edge information that highlight recent and ongoing developments and research within environmental science. This work demonstrates how understanding environmental science and theology can provide new resources for sustaining the Earth.
Transnational Water Management for Beginners
Poor water quality has resulted in major problems in many developing countries, affecting the overall socioeconomic status of communities as well as the ecological situation of various surrounding environments. This, together with changing climatic conditions, increases in industrial activities, and changes in land use, has led to an ex¬acerbation of water-related problems. Nowadays, water-related issues have infiltrated into many different areas such as the environment, energy, industry, transport, food security, society, health, and even climate sectors. Often these tend to impact at both the national and international scale. The increased demand for water has often placed an enhanced ris...
A Simple Guide to Understanding Medical Device Regulations
As innovation and rapid advancement in technologies take over, medical devices have now become one of the fastest-growing industries globally. In 2000, it was estimated that one and half million different medical devices were available on the market worldwide. For many countries, their regulatory systems have proven to be ineffective in quality management and in monitoring the domestic market to prevent unsafe and low-quality medical products from entering. The lack of harmonized processes when assessing the safety and efficacy or performance of medical products has also led to an increase in costs associated with licensing where required. Regulatory controls for medical devices are often co...
Encyclopedia of Environmental Science, Volume 6
Water resources and services are integrated measures of social systems that range beyond the technical world and the IWRM requires a balance between competing views of social and political issues. This volume focuses on increased awareness of the human dimension, the role of women, environmental protection, sustainability and food security aspects in achieving sustainable water management.
The Medical Device Handbook for Europe
As the medical device landscape continues to evolve, so does the regulatory framework in Europe. Through this process many gaps and scarcity of skills and expertise have also been identified. For this reason, there was an increasing need to update the current medical device directive (MDD 93/42/EEC) being used within the European Union. This in turn led to the development and release of the Medical Device Regulation (EU MDR 2017/745). The release of the new Medical Device Regulation (EU MDR 2017/745) in 2017 marked the start of a three-year transition period for various Economic Operators along the supply chain. This volume aims to provide a simple overview of the medical device industry in Europe with particular focus on the main aspects covered in the new European Medical Device Regulation. Important concepts such as essential phases in a device lifecycle, complying to standards and regulations, the CE mark process and classification of medical devices in Europe are covered.
Encyclopedia of Environmental Science, Volume 7
Dealing with the principles of economics to the study of how environmental and natural resources are developed and managed; this volume is packed with novel approaches to the formulation of environmental policy by establishing the links between the environment and the economy, such as renewable energy, construction of hydroelectric power plants or transnational pipelines, and pollution control measures.
