ISO/TR 24971 : medical devices - guidance on the application of ISO 14971 PDF Download
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Author: ISO.
Publisher:
ISBN:
Category :
Languages : en
Pages : 0
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Author: ISO.
Publisher:
ISBN:
Category :
Languages : en
Pages : 0
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Author:
Publisher:
ISBN:
Category :
Languages : en
Pages : 12
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Author: Singapore Standards Council
Publisher:
ISBN: 9789814925075
Category : Medical instruments and apparatus
Languages : en
Pages : 111
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Author: British Standards Institution
Publisher:
ISBN:
Category :
Languages : en
Pages : 96
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Author: British Standards Institution
Publisher:
ISBN:
Category :
Languages : en
Pages : 214
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Author: Association for the Advancement of Medical Instrumentation
Publisher:
ISBN:
Category : Materials
Languages : en
Pages : 0
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Author: British Standards Institute Staff
Publisher:
ISBN: 9780580752704
Category :
Languages : en
Pages : 24
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Book Description
Medical equipment, Electrical medical equipment, Medical instruments, Terminology, Information exchange, Data processing, Classification systems, Thesauri, Data structures, Data handling, Sets of data, Data organization, Databases, Data representation
Author: British Standards Institution
Publisher:
ISBN:
Category :
Languages : en
Pages : 0
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Author: Ben Potter
Publisher:
ISBN:
Category : Computers
Languages : en
Pages : 456
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Book Description
Following the sucess of the first edition, the authors have updated and revised this bestselling textbook to take into account the changes in the subject over the past 5 years.
Author: Amiram Daniel
Publisher: Quality Press
ISBN: 0873897404
Category : Medical
Languages : en
Pages : 355
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Book Description
How have recent changes in domestic and international regulations affected quality management in the development and marketing of medical devices in the US and abroad? Consultants Daniel and Kimmelman take a close look at the Quality System Regulation (QsReg), the ISO 13485: 2003 standard and the ISO/TR 14969: 2004 guidance document as well as a number of US Food and Drug Administration (FDA) and Global Harmonization Task Force (GHTF) guidance documents. The authors provide extensive commentary and notes an update their material to include such topics as the incorporation of principles of risk management into the medical device organizations' quality management systems (QMSs) and considerations of combination products. Daniel and Kimmelman include full coverage of the QSReg requirements, descriptions of comparable requirements in the ISO documents, excerpts of the FDA's responses to the QSReg preamble and excerpts from FDA guidance documents related to QMSs.
