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News Release from: BSI British Standards | Subject: Medical Devices: ISO 13485 and ISO 9001
Edited by the Manufacturingtalk Editorial
Team on 17 August 2005
Medical device standards and regulations
explained
The medical devices sector is highly regulated with standards, rules and legislation.
The medical devices sector is highly regulated with standards, rules and legislation To help manufacturers negotiate through the minefield of regulations, a brand new book authored by Dr Dennis Green, Medical Devices: ISO 13485 and ISO 9001 has just been published by BSI Business Information
This article was originally published on Manufacturingtalk on 20 Sep 2005 at 8.00am (UK)
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This book is for those who are responsible for seeking compliance with the requirements of the quality management systems standard ISO 13485 on medical devices.
Many aspects of this standard are identical to ISO 9001, meaning that accredited certification to both standards can be achieved at the same time, relatively easily.
In addition the continual improvement aspect of ISO 9001 can offer real gains and competitive advantage to those who manufacture and service medical devices.
This book takes the reader through the clauses of both standards, providing essential information on ISO 13485, ISO 9001 and quality management systems auditing.
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