E-update - 19 February 2013
Get your copy of the new ‘go to’ guide for medical device trials
The book explains, in clear terms, how to comply with BS EN ISO 14155:2011 (Clinical investigation of medical devices for human subjects). BS EN ISO 14155:2011 was formed by the revision and merging of BS EN ISO 14155:2009, Parts 1 and 2. It highlights the differences between the old standards and the new one, documenting the major changes introduced. It also describes in detail the regulations, directives and standards governing medical devices and clinical trials.
Step by step
It describes the process of initiating, conducting and reporting on a clinical investigation, with supporting industry examples of where problems can arise. It provides a reference as to how clinical trials of medical devices should be conducted.
Who is it for?
It is a ‘go to’ guide for new researchers and a worthy reference source for experienced researchers, whilst providing an insight into the area of clinical trials for anyone involved in the production or marketing of medical devices.
About the author
Duncan Fatz is an independent healthcare consultant and writer specializing in medical devices. As a clinical trials coordinator for the UK's North West Thames Health Authority, a researcher for the Medical Research Council and independent consultant and lecturer, Duncan has been guiding medical device companies and their products through the clinical trial process and on to subsequent reimbursement approval in the major European markets for almost 20 years
Download your free chapter and buy the book.
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Medical devices. Application of risk management to medical devices (BS EN ISO 14971:2012)
Clinical investigation of medical devices for human subjects. Good clinical practice (BS EN ISO 14155:2011)