The Essential Principles of Safety and Effectiveness for Medical Devices and the Role of Standards

Saleh S Altayyar Correspondence: Saleh S AltayyarBiomedical Technology Department, College of Applied Medical Sciences, King Saud University, P.O.Box 53831, Riyadh 11593, Saudi ArabiaTel +966505456035Email stayyar@ksu.edu.saPurpose: A medical device may be of any type such as appliance, in vitro usa...

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Autor principal:	Altayyar SS
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2020
Materias:	essential principles of safety and performance effectiveness medical devices performance medical devices safety Medical technology R855-855.5
Acceso en línea:	https://doaj.org/article/503cdc94b693479e80d6512cf2fbe6b0
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spelling	oai:doaj.org-article:503cdc94b693479e80d6512cf2fbe6b02021-12-02T04:53:59ZThe Essential Principles of Safety and Effectiveness for Medical Devices and the Role of Standards1179-1470https://doaj.org/article/503cdc94b693479e80d6512cf2fbe6b02020-02-01T00:00:00Zhttps://www.dovepress.com/the-essential-principles-of-safety-and-effectiveness-for-medical-devic-peer-reviewed-article-MDERhttps://doaj.org/toc/1179-1470Saleh S Altayyar Correspondence: Saleh S AltayyarBiomedical Technology Department, College of Applied Medical Sciences, King Saud University, P.O.Box 53831, Riyadh 11593, Saudi ArabiaTel +966505456035Email stayyar@ksu.edu.saPurpose: A medical device may be of any type such as appliance, in vitro usable reagents, apparatus, instrument, machine, implement, material, software or other related articles. Either as a single entity or in combination, these devices are used by the skilled persons as per the manufacturer’s instructions to prevent, diagnose, treat, monitor, alleviate the disease, compensate for an injury, investigate, replace, modify or support the anatomy in human beings.Methods: Using standards is a voluntary process unless and until it is identified as a mandatory one by the regulatory authority. The manufacturers must demonstrate that the medical devices they manufacture meet the relevant Essential Principles of Safety and Performance and are freely accessible to public.Results: Various national and international standards (not recognized by the regulatory authority), industrial standards, manufacturer-developed Standard Operating Procedures (not related to international standards), non-recognized standards, and state-of-the-art techniques are in process in terms of performance, material, design, methods, process or practices.Conclusion: The regulatory authority needs to ensure whether the manufacturer has implemented the risk management processes and met the regulatory requirements set. The responsibility towards medical devices safety and performance lies with both manufacturer and the regulatory authority.Keywords: essential principles of safety and performance, effectiveness, medical devices performance, medical devices safetyAltayyar SSDove Medical Pressarticleessential principles of safety and performanceeffectivenessmedical devices performancemedical devices safetyMedical technologyR855-855.5ENMedical Devices: Evidence and Research, Vol Volume 13, Pp 49-55 (2020)
institution	DOAJ
collection	DOAJ
language	EN
topic	essential principles of safety and performance effectiveness medical devices performance medical devices safety Medical technology R855-855.5
spellingShingle	essential principles of safety and performance effectiveness medical devices performance medical devices safety Medical technology R855-855.5 Altayyar SS The Essential Principles of Safety and Effectiveness for Medical Devices and the Role of Standards
description	Saleh S Altayyar Correspondence: Saleh S AltayyarBiomedical Technology Department, College of Applied Medical Sciences, King Saud University, P.O.Box 53831, Riyadh 11593, Saudi ArabiaTel +966505456035Email stayyar@ksu.edu.saPurpose: A medical device may be of any type such as appliance, in vitro usable reagents, apparatus, instrument, machine, implement, material, software or other related articles. Either as a single entity or in combination, these devices are used by the skilled persons as per the manufacturer’s instructions to prevent, diagnose, treat, monitor, alleviate the disease, compensate for an injury, investigate, replace, modify or support the anatomy in human beings.Methods: Using standards is a voluntary process unless and until it is identified as a mandatory one by the regulatory authority. The manufacturers must demonstrate that the medical devices they manufacture meet the relevant Essential Principles of Safety and Performance and are freely accessible to public.Results: Various national and international standards (not recognized by the regulatory authority), industrial standards, manufacturer-developed Standard Operating Procedures (not related to international standards), non-recognized standards, and state-of-the-art techniques are in process in terms of performance, material, design, methods, process or practices.Conclusion: The regulatory authority needs to ensure whether the manufacturer has implemented the risk management processes and met the regulatory requirements set. The responsibility towards medical devices safety and performance lies with both manufacturer and the regulatory authority.Keywords: essential principles of safety and performance, effectiveness, medical devices performance, medical devices safety
format	article
author	Altayyar SS
author_facet	Altayyar SS
author_sort	Altayyar SS
title	The Essential Principles of Safety and Effectiveness for Medical Devices and the Role of Standards
title_short	The Essential Principles of Safety and Effectiveness for Medical Devices and the Role of Standards
title_full	The Essential Principles of Safety and Effectiveness for Medical Devices and the Role of Standards
title_fullStr	The Essential Principles of Safety and Effectiveness for Medical Devices and the Role of Standards
title_full_unstemmed	The Essential Principles of Safety and Effectiveness for Medical Devices and the Role of Standards
title_sort	essential principles of safety and effectiveness for medical devices and the role of standards
publisher	Dove Medical Press
publishDate	2020
url	https://doaj.org/article/503cdc94b693479e80d6512cf2fbe6b0
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The Essential Principles of Safety and Effectiveness for Medical Devices and the Role of Standards

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