Articoli correlati a Quality and Validation Handbook: for Medical Devices
Sinossi
Innovation in medical devices has transformed medical treatments and patient outcomes dramatically in recent times. The efforts to bring new products to market and maintain effective and safe products through their lifecycle depends on multiple factors- too many to mention.
While need often drives the innovation and demand, new technology and manufacturing capabilities offer new dimensions for products and medical devices. The technology on offer continues to evolve. Manufacturing, while rooted in engineering and physical principles is also subject to change, with increased automation, high volume manufacturing and software powered solutions.
With this landscape in mind, it is important to maintain structures that allow product development and realisation to deliver in a safe and effective way. To this end, there are well established systems and standards that facilitate product design and development in a safe manner that is also beneficial to the manufacturer. Specifically, Quality Management Systems intended for medical devices offer effective frameworks that help fulfil regulatory requirements and provide generally acknowledged state of the art information.
This book examines the integrated nature of many of the processes and sub processes in typical quality management systems. While statutory requirements and published standards provide the core requirements and how they should be applied, the aim of this publication is to illustrate the interdependencies within a Medical Device Quality Management System.
Page Count 170 pages (7inch x 10 inch)
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Quality And Validation Handbook: For Medical Devices
Da: Bookbot, Prague, Repubblica Ceca
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Softcover. Condizione: Fine. Leichte Kratzer / Abnutzungen / Druckstellen; Gebrochener Buchrücken / Seiten oder Softcover umgeknickt; Vergilbt / ausgeblichen. Codice articolo 03a27eb6-4ca2-4958-ac5e-716953f9e97a
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