Medical device regulatory practices : an international perspective

Medical Regulatory Affairs: An Internati

📁 Medical Regulatory Affairs: An International Handbook for Medical Devices and Healthcare Products

✍ Jack Wong, Raymond Tong 📂 Library 📅 2022 🏛 Jenny Stanford Publishing 🌐 English

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 interna

Local Public Finance: An International C

📁 Local Public Finance: An International Comparative Regulatory Perspective

✍ René Geissler (editor), Gerhard Hammerschmid (editor), Christian Raffer (editor) 📂 Library 📅 2021 🏛 Springer 🌐 English

This book is based upon a comparative public administration research project, initiated by the Hertie School of Governance (Germany) and the Bertelsmann Foundation (Germany) and supported by a network of researchers from many EU countries. It analyzes both the regimes and the practices of loca

Safety Evaluation of Pharmaceuticals and

📁 Safety Evaluation of Pharmaceuticals and Medical Devices: International Regulatory Guidelines

✍ Shayne C. Gad (auth.) 📂 Library 📅 2011 🏛 Springer US 🌐 English

Safety Evaluation of Pharmaceuticals and Medical Devices has been written to provide complete, ready and clear guidance as to what nonclinical safety assessment tests need to be performed to move a regulated therapeutic medical product into and through the development process and to marketing

Safety Evaluation of Pharmaceuticals and

📁 Safety Evaluation of Pharmaceuticals and Medical Devices: International Regulatory Guidelines

✍ Shayne C. Gad (auth.) 📂 Library 📅 2011 🏛 Springer US 🌐 English

Safety Evaluation of Pharmaceuticals and Medical Devices has been written to provide complete, ready and clear guidance as to what nonclinical safety assessment tests need to be performed to move a regulated therapeutic medical product into and through the development process and to marketing

Medical Product Regulatory Affairs: Phar

📁 Medical Product Regulatory Affairs: Pharmaceuticals, Diagnostics, Medical Devices

✍ John J. Tobin, Gary Walsh 📂 Library 📅 2008 🏛 Wiley-VCH 🌐 English

Written in a clear and concise by experienced authors, this book covers regulatory affairs in all major global markets for pharmaceuticals and medical devices.Following a look at drug development, complete sections are devoted to national and EU regulatory issues, manufacturing license application a

International Medical Device Clinical In

📁 International Medical Device Clinical Investigations: A Practical Approach

✍ Herman Pieterse, Peter Duijst, M. G. de Jong 📂 Library 📅 1999 🏛 CRC Press 🌐 English

The demand for clinical evidence has become an increasingly important issue in the development of medical devices. This demand is reflected not only in regulatory requirements but also by healthcare purchasers as healthcare reforms occur worldwide. Thirteen renowned experts have drawn on their pract