Canadian Medical Device Regulation

The Biomaterials Science and Engineering Series is designed to help stimulate further developments in biomaterials science and engineering by disseminating up-to-the-minute, quality information to academic and industrial research and development scientists employed in all areas of the medical, biomedical and bioengineering sciences whether in medical device R&D, pharmaceutical and pharmacological research or materials science, and to clinical specialists in prosthesis and surgery. Biocompatibility Assessment of Medical Devices and Materials presents both an overview and forward assessment of medical device materials and test methods. Highlighting the complex problem of host responses and related issues which may restrict the accuracy and reliability of existing test methodology, the book provides an unbiased appraisal of the requirements for biocompatibility and the approaches that have been developed to evaluate it. This much-needed volume specifically addresses: The rapid development of regulation and standards in the biomedical field over recent years.The test methods necessary as part of the evaluation of safety of medical materials and devices.The advantages of standardised, valid analytical measurement, inter- and intra-laboratory testing and certified reference materials.The problems of surface interaction evaluation, processing techniques and degradation effects.The application of risk analysis to assessment of biological safety, including the very latest protocols.In summary, this book provides readers with a comprehensive understanding of the principles involved in the use and interpretation of the current and emerging standards and directives necessary for the evaluationof the biological safety of materials and devices for use in medical applications.

-- Examines the development and present state of safety regulations for medical devices world wide. -- Written for graduate students and professionals in biomedical engineering and medical physics, especially those concerned with device development. -- Major market will be industrial, i.e. device manufacturers. -- Gordon Higson is regarded as the key opinion leader in the area of global regulatory harmonisation and a founder member of the Global Harmonisation Task Force. -- No present competition.

Canadian Medical Association Journal - The Canadian Medical Association Journal (CMAJ) is a general medical journal that is published bimonthly in Canada by the Canadian Medical Association (CMA). It was established in 1911.

Canadian Forces Medical Service - The Canadian Forces Medical Service (CFMS) provides medical support for the Canadian Armed Forces both at home and abroad. It was formed in 1885 in response to the Northwest Rebellion with the appointment of Canada's first Surgeon General, Doctor Darby Bergin of Cornwall, Ontario.

Canadian Medical Hall of Fame - The Canadian Medical Hall of Fame is a Canadian charitable organization, founded in 1994, that honours Canadians who have contributed to the understanding of disease and improving the health of people. It has a museum in London, Ontario, and an annual induction ceremony.

Canadian Medical Association - The Canadian Medical Association (CMA) is the largest association of doctors in Canada and works to represent their interests nationally. It formed in 1867, three months after Confederation.

canadianmedicaldeviceregulation

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