Export of Medical Devices
Author | : |
Publisher | : |
Total Pages | : 220 |
Release | : 1988 |
Genre | : Commerce |
ISBN | : |
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Author | : |
Publisher | : |
Total Pages | : 220 |
Release | : 1988 |
Genre | : Commerce |
ISBN | : |
Author | : I. Glenn Cohen |
Publisher | : Cambridge University Press |
Total Pages | : 295 |
Release | : 2022-04-07 |
Genre | : Law |
ISBN | : 1108838634 |
A detailed analysis of the ethical, legal, and regulatory landscape of medical devices in the US and EU.
Author | : |
Publisher | : |
Total Pages | : 332 |
Release | : 1983 |
Genre | : Foreign trade regulation |
ISBN | : |
Author | : |
Publisher | : |
Total Pages | : |
Release | : 1990 |
Genre | : Medical instruments and apparatus |
ISBN | : |
Author | : |
Publisher | : |
Total Pages | : 0 |
Release | : 1983 |
Genre | : Foreign trade regulation |
ISBN | : |
Author | : |
Publisher | : |
Total Pages | : 64 |
Release | : 1983 |
Genre | : Medical instruments and apparatus |
ISBN | : |
Author | : Center for Devices and Radiological Health (U.S.). Division of Small Manufacturers Assistance |
Publisher | : |
Total Pages | : 47 |
Release | : 1985 |
Genre | : Medical instruments and apparatus |
ISBN | : |
Author | : United States. Food and Drug Administration |
Publisher | : |
Total Pages | : |
Release | : 1997 |
Genre | : Foreign trade regulation |
ISBN | : |
Author | : Vinny R. Sastri |
Publisher | : Elsevier |
Total Pages | : 289 |
Release | : 2010-03-05 |
Genre | : Technology & Engineering |
ISBN | : 081552028X |
No book has been published that gives a detailed description of all the types of plastic materials used in medical devices, the unique requirements that the materials need to comply with and the ways standard plastics can be modified to meet such needs. This book will start with an introduction to medical devices, their classification and some of the regulations (both US and global) that affect their design, production and sale. A couple of chapters will focus on all the requirements that plastics need to meet for medical device applications. The subsequent chapters describe the various types of plastic materials, their properties profiles, the advantages and disadvantages for medical device applications, the techniques by which their properties can be enhanced, and real-world examples of their use. Comparative tables will allow readers to find the right classes of materials suitable for their applications or new product development needs.
Author | : Michael Cheng |
Publisher | : World Health Organization |
Total Pages | : 54 |
Release | : 2003-09-16 |
Genre | : Medical |
ISBN | : 9241546182 |
The term 'medical devices' covers a wide range of equipment essential for patient care at every level of the health service, whether at the bedside, at a health clinic or in a large specialised hospital. Yet many countries lack access to high-quality devices, particularly in developing countries where health technology assessments are rare and there is a lack of regulatory controls to prevent the use of substandard devices. This publication provides a guidance framework for countries wishing to create or modify their own regulatory systems for medical devices, based on best practice experience in other countries. Issues highlighted include: the need for harmonised regulations; and the adoption, where appropriate, of device approvals of advanced regulatory systems to avoid an unnecessary drain on scarce resources. These approaches allow emphasis to be placed on locally-assessed needs, including vendor and device registration, training and surveillance and information exchange systems.