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Regulatory Affairs for Biomaterials and Medical Devices

S Amato, B Ezzell
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      All biomaterials and medical devices are subject to a long list of regulatory practises and policies which must be adhered to in order to receive clearance. This book provides readers with information on the systems in place in the USA and the rest of the world. Chapters focus on a series of procedures and policies including topics such as commercialization, clinical development, general good practise manufacturing and post market surveillance.
      Format: CONTRIBUTORS: S Amato, B Ezzell EAN: 9780857095428 COUNTRY: United Kingdom PAGES: WEIGHT: 440 g HEIGHT: 229 cm
      PUBLISHED BY: Elsevier Science & Technology DATE PUBLISHED: 2014-10-16 CITY: GENRE: LAW / Administrative Law & Regulatory Practice, MEDICAL / Instruments & Supplies, TECHNOLOGY & ENGINEERING / Biomedical WIDTH: 152 cm SPINE:

      Book Themes:

      Medical equipment and techniques

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      Dr Amato teaches at Northeastern University, is a senior lecturer at Boston College and serves on the board of directors for several organizations, including BioSignostix, the Medical Development Group (MDG) and the Association of Graduate Regulatory Educators (AGRE). His research has been extensively published and he has presented on regulatory affairs across the United States, China and India.
      All biomaterials and medical devices are subject to a long list of regulatory practises and policies which must be adhered to in order to receive clearance. This book provides readers with information on the systems in place in the USA and the rest of the world. Chapters focus on a series of procedures and policies including topics such as commercialization, clinical development, general good practise manufacturing and post market surveillance.
      Format: CONTRIBUTORS: S Amato, B Ezzell EAN: 9780857095428 COUNTRY: United Kingdom PAGES: WEIGHT: 440 g HEIGHT: 229 cm
      PUBLISHED BY: Elsevier Science & Technology DATE PUBLISHED: 2014-10-16 CITY: GENRE: LAW / Administrative Law & Regulatory Practice, MEDICAL / Instruments & Supplies, TECHNOLOGY & ENGINEERING / Biomedical WIDTH: 152 cm SPINE:

      Book Themes:

      Medical equipment and techniques

      Customer Reviews

      Be the first to write a review
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      Dr Amato teaches at Northeastern University, is a senior lecturer at Boston College and serves on the board of directors for several organizations, including BioSignostix, the Medical Development Group (MDG) and the Association of Graduate Regulatory Educators (AGRE). His research has been extensively published and he has presented on regulatory affairs across the United States, China and India.

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