Global Medical Device Regulation: Emphasis on Active Implants

Language: English

Published by LAP LAMBERT Academic Publishing Aug 2013, 2013

3659445738 / 9783659445736

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This item is printed on demand - Print on Demand Titel. Neuware -Regulations for medical devices in EU Member countries are governed by European Medicine Evaluation Authority, popularly known as EMEA. As per EMEA's guideline each member country has to strictly follow the common guidelines with exception to rules and regulation that are modified by state authorities but must be in conformity with EMEA Guideline. Regulations posed in here are further divided in implantable and active implantable medical devices thereafter where manufacturing, testing and distribution can only be done once it is CE marked. In case of non CE marked devices i.e. non-EU member manufacturer, market authorisation process shall be completed prior to approval and separately. For brazil market that is governed by ANVISA, medical devices are classified into four different classes. There is no independent discrimination made for Active implantable medical devices but most non invasive devices are covered in Class I. While those which are to be connected with blood storage and other devices are classified into class II. Class III devices are those which are connected or included with wounds or healthy tissues.VDM Verlag, Dudweiler Landstraße 99, 66123 Saarbrücken 144 pp. Englisch.

Seller Inventory # 9783659445736

Title
Global Medical Device Regulation: Emphasis on Active Implants
Author
Keyur N. Patel
Publisher
LAP LAMBERT Academic Publishing Aug 2013
Publication year
2013
Condition
Neu
Binding
Taschenbuch
Language
English
ISBN 10
3659445738
ISBN 13
9783659445736
Item weight
233 grams
Dimensions
220x150x10 mm

buchversandmimpf2000

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