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Fundamentals of Us Regulatory Affairs 2005
Directives and regulations governing healthcare products in the EU.
Handbook of Medical Device Regulatory Affairs in Asia
Medical device regulation in Asia has gained more importance than ever. Governments and regulatory bodies across the region have put in place new regulatory systems or refined the existing ones. A registered product requires a lot of technical documentation to prove its efficacy, safety, and quality. A smooth and successful registration process demands soft skills for dealing with various key stakeholders in the government, testing centers, and hospitals and among doctors. Handbook of Medical Device Regulatory Affairs in Asia covers medical device regulatory systems in different countries, ISO standards for medical devices, clinical trial and regulatory requirements, and documentation for application. Government bodies, the medical device industry, and academics and students will find this book immensely useful in understanding the global regulatory environment and in their research and development projects.
Medical Regulatory Affairs
This handbook covers medical device regulatory systems in different countries, ISO standards for medical devices, clinical trial and regulatory requirements, and documentation for application. It is the first to cover the medical device regulatory affairs in Asia. Experts from influential international regulatory bodies, including the US Food and Drug Administration (FDA), UK Medicines and Healthcare Products Regulatory Agency, Japan Pharmaceuticals and Medical Devices Agency, Saudi Food and Drug Authority, Korea Testing Laboratory, Taiwan FDA, World Health Organization, Asian Harmonization Working Party, Regulatory Affairs Professionals Society, and British Standards Institution, have contributed to the book. Government bodies, the medical device industry, academics, students, and general readers will find the book immensely useful for understanding the global regulatory environment and in their research and development projects.
A Minimally Invasive System for the Evaluation of Prosthetic Heart Valves
This thesis describes a minimally invasive electromagnetic approach, called the gradiometer-based method, for detecting [single-leg separation of the heart valve strut] failures. The feasibility of the method is investigated using three-dimensional finite element analysis techniques.
Handbook of Medical Device Regulatory Affairs in Asia
Medical device regulation in Asia has gained more importance than ever. Governments and regulatory bodies across the region have put in place new regulatory systems or refined the existing ones. A registered product requires a lot of technical documentation to prove its efficacy, safety, and quality. A smooth and successful registration process demands soft skills for dealing with various key stakeholders in the government, testing centers, and hospitals and among doctors. This handbook covers medical device regulatory systems in different countries, ISO standards for medical devices, clinical trial and regulatory requirements, and documentation for application. It is the first to cover the medical device regulatory affairs in Asia. Each chapter provides substantial background materials relevant to the particular area to have a better understanding of regulatory affairs.
The Dawn of Dutch
The Low Countries are famous for their radically changing landscape over the last 1,000 years. Like the landscape, the linguistic situation has also undergone major changes. In Holland, an early form of Frisian was spoken until, very roughly, 1100, and in parts of North Holland it disappeared even later. The hunt for traces of Frisian or Ingvaeonic in the dialects of the western Low Countries has been going on for around 150 years, but a synthesis of the available evidence has never appeared. The main aim of this book is to fill that gap. It follows the lead of many recent studies on the nature and effects of language contact situations in the past. The topic is approached from two different angles: Dutch dialectology, in all its geographic and diachronic variation, and comparative Germanic linguistics. In the end, the minute details and the bigger picture merge into one possible account of the early and high medieval processes that determined the make-up of western Dutch.
Indian Puppets
Puppetry Originated In India And Travelled Across The Seven Seas To The Eastern And Western World As Vouched By Many Scholars. Puppets Dated Back To A Period Well Before Bharata S Natya Shastra And Have Continued Unabated Throughout The Centuries In Almost All Indian States. Puppetry Is One Enduring Form, Which Has Entertained Masses And Educated People. The Famous Puppeteers Of Rajasthan Are Really Acrobats, Who Only Put On Puppet Shows When They Move Out Of Villages. These And A Thousand Other Scintillating Facts Come Out Of This Exciting Book For The Reader S Entertainment And Elucidation. Puppets Are By No Means For Only Children, -- As The Puppeteers Of Orissa Sing And Dance About The R...
Neurochemistry
Proceedings of the 11th European Society for Neurochemistry Meeting held in Groningen, The Netherlandes, June 15-20, 1996
Multi-Agent Systems and Applications IV
The aim of the CEEMAS conference series is to provide a biennial forum for the presentation of multi-agent research and development results. With its p- ticular geographicalorientation towards Central and Eastern Europe, CEEMAS has become an internationally recognised event with participants from all over the world. After the successful CEEMAS conferences in St. Petersburg (1999), Cracow (2001) and Prague (2003), the 2005 CEEMAS conference takes place in Budapest. The programme committee of the conference series consists of est- lished researchers from the region and renowned international colleagues, sh- ing the prominent rank of CEEMAS among the leading events in multi-agent systems. In th...
