Download or read book Medical Devices written by and published by . This book was released on 2019 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: This document specifies terminology, principles and a process for risk management of medical devices, including software as a medical device and in vitro diagnostic medical devices. The process described in this document intends to assist manufacturers of medical devices to identify the hazards associated with the medical device, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls. The requirements of this document are applicable to all phases of the life cycle of a medical device. The process described in this document applies to risks associated with a medical device, such as risks related to biocompatibility, data and systems security, electricity, moving parts, radiation, and usability. The process described in this document can also be applied to products that are not necessarily medical devices in some jurisdictions and can also be used by others involved in the medical device life cycle. This document does not apply to: decisions on the use of a medical device in the context of any particular clinical procedure; or business risk management. This document requires manufacturers to establish objective criteria for risk acceptability but does not specify acceptable risk levels. Risk management can be an integral part of a quality management system. However, this document does not require the manufacturer to have a quality management system in place. NOTE Guidance on the application of this document can be found in ISO/TR 24971-- Scope, page 1.

Download or read book Medical Devices written by ISO/TC 210 Quality management and corresponding general aspects for medical devices (Committee) and published by . This book was released on 2019 with total page 36 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Medical Devices Application of Risk Management to Medical Devices written by British Standards Institute Staff and published by . This book was released on 2009-07-31 with total page 96 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical equipment, Medical instruments, Risk assessment, Risk analysis, Management, Hazards, Clinical investigation instruments, Safety measures, Diagnosis (medical)

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Download or read book Medical Devices Application of Risk Management to Medical Devices written by Association for the Advancement of Medical Instrumentation and published by . This book was released on 2003-07 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:

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Download or read book Medical Devices Application of Risk Management to Medical Devices written by and published by . This book was released on 2007 with total page 82 pages. Available in PDF, EPUB and Kindle. Book excerpt:

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Download or read book ISO 14971 written by International Organization for Standardization and published by . This book was released on 2000 with total page 32 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Medical Devices Application of Risk Management to Medical Devices written by and published by . This book was released on 2003 with total page 7 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Medical Devices Application of Risk Management to Medical Devices corrected and Reprinted ISO 14971 2007 07 IDT written by Nederlands Normalisatie-instituut and published by . This book was released on 2009 with total page 82 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Medical Devices Application of Risk Management to Medical Devises written by International Organization for Standardization and published by . This book was released on 2000 with total page 32 pages. Available in PDF, EPUB and Kindle. Book excerpt:

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Download or read book Medical Devices written by Singapore Standards Council and published by . This book was released on 2017 with total page 94 pages. Available in PDF, EPUB and Kindle. Book excerpt: