Medical Device Regulatory Practices: An International Perspective
- ISBN-10
- 9814669113
- ISBN-13
- 9789814669115
- Category
- Medical
- Pages
- 590
- Language
- English
- Published
- 2015-08-03
- Publisher
- CRC Press
- Author
- Val Theisz
Description
This book is intended to serve as a reference for professionals in the medical device industry, particularly those seeking to learn from practical examples and case studies. Medical devices, like pharmaceuticals, are highly regulated, and the bar is raised constantly as patients and consumers expect the best-quality healthcare and safe and effective medical technologies. Obtaining marketing authorization is the first major hurdle that med techs need to overcome in their pursuit of commercial success. Most books on regulatory affairs present regulations in each jurisdiction separately: European Union, USA, Australia, Canada, and Japan. This book proposes practical solutions for a coherent, one-size-fits-all (or most) set of systems and processes in compliance with regulations in all key markets, throughout the life cycle of a medical device. It also contains key information about international harmonization efforts and recent regulatory trends in emerging markets; important terminology needed to understand the regulators’ language; and examples, case studies, and practical recommendations that bridge the gap between regulatory theory and practice.
Get the book
Similar books
-
How Institutions are Shaping the Future of Our Children: For Better or for Worse?
By Catherine Dulmus, Karen SowersLammert, M., & Timberlake, E. M. (1986). Termination of foster care for the older adolescent: Issues of emancipation and individuation.
-
Reversibility of Chronic Disease and Hypersensitivity, Volume 5: Treatment Options of Chemical Sensitivity
By William J. Rea, Kalpana D. PatelDou, L., E. Bertrand, C. Cerini, V. Faure, J. Sampol, R. Vanholder, Y. Berland, P. Brunet. ... A. Timberlake, B. Sumpio, R. Pfragner, I. M. Modlin, M. Kidd.
-
Rockwood and Green's Fractures in Adults
By William Ricci, Charles M. Court-Brown, Margaret M. McQueenChendrasekhar A, Moorman DW, Timberlake GA. An evaluation of the effects of ... Chittiboina P, Wylen E, Ogden A, et al. Traumatic spondylolisthesis of the ...
-
Breast Pathology, An Issue of Surgical Pathology Clinics
By Laura C. CollinsHartmann LC, Radisky DC, Frost MH, et al. Understanding the premalignant potential of ... D'Alfonso TM, Wang K, Chiu YL, et al. Pathologic upgrade rates on ...
-
Telepractice in Speech-Language Pathology
By K. Todd HoustonStensland, J., Speedie, S., Ideker, M., House, J., & Thompson, T. (1999). The relative cost of outpatient ... Deal, J. L. (1987). Appraisal and diagnosis of ...
-
Addressing Adversity: Prioritising adversity and trauma-informed care for children and young people in England.
By Marc Bush, Lord Victor Adebowale, Rebecca Adlington1 2 Howard, S. and Johnson, B. (2000) Resilient and Non-resilient Behaviour in ... 4 De Haan, L., Hawley, D. and Deal, J. (2002) 'Operationalizing family ...
-
Culture, Brain, and Analgesia: Understanding and Managing Pain in Diverse Populations
By Mario Incayawar, Knox H. Todd... are not fluent in the language/s of the medical care provider.72 Research ... Anglo-Americans have traditionally placed a great deal of emphasis on the ...
-
Image-Guided Spine Interventions
By John M. MathisThis practical guide thoroughly discusses both well-established and new interventions that are applied to the spine for the purpose of pain relief.
-
New Mynursinglab -- Access Card -- For Maternal-Child Nursing (24-Month Access)
By Pearson Education, Pearson Education, Inc., David P Pearson EducationSeveral versions of Pearson's MyLab & Mastering products exist for each title, including customized versions for individual schools, and registrations are not transferable.
-
Pearson's Medical Assisting (General)
By Pearson Education Staff, Madan Dr Pearson EducationIf a picture paints a thousand words, imagine what video can do? Pearson Medical Assisting Videos help users learn the nuances and the details of many medical assisting procedures.