Author:
Publisher:
ISBN:
Category : Diagnosis, Laboratory
Languages : en
Pages : 48
Book Description
Guideline for the Manufacture of in Vitro Diagnostic Products
Author:
Publisher:
ISBN:
Category : Diagnosis, Laboratory
Languages : en
Pages : 48
Book Description
Publisher:
ISBN:
Category : Diagnosis, Laboratory
Languages : en
Pages : 48
Book Description
GMP Guidelines for the Manufacture of in Vitro Diagnostic Products
Author: Center for Devices and Radiological Health (U.S.)
Publisher:
ISBN:
Category : Medical instruments and apparatus industry
Languages : en
Pages : 28
Book Description
Publisher:
ISBN:
Category : Medical instruments and apparatus industry
Languages : en
Pages : 28
Book Description
In Vitro Diagnostic Devices
Author: Alfred Bracey
Publisher:
ISBN:
Category : Medical instruments and apparatus
Languages : en
Pages : 78
Book Description
Publisher:
ISBN:
Category : Medical instruments and apparatus
Languages : en
Pages : 78
Book Description
Evaluation of Stability of in Vitro Diagnostic Reagents
Author: James F. Pierson-Perry
Publisher:
ISBN:
Category : Diagnostic reagents and test kits
Languages : en
Pages : 0
Book Description
"provides guidance and regression-based procedures for establishing stability-related claims on in vitro diagnostic (IVD) reagents such as reagent kits, calibrators, control products, and sample diluents. This guideline was written primarily for manufacturers and regulatory agencies, but will also be of interest to clinincal laboratories"--Cover.
Publisher:
ISBN:
Category : Diagnostic reagents and test kits
Languages : en
Pages : 0
Book Description
"provides guidance and regression-based procedures for establishing stability-related claims on in vitro diagnostic (IVD) reagents such as reagent kits, calibrators, control products, and sample diluents. This guideline was written primarily for manufacturers and regulatory agencies, but will also be of interest to clinincal laboratories"--Cover.
Public Health Effectiveness of the FDA 510(k) Clearance Process
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309162904
Category : Medical
Languages : en
Pages : 141
Book Description
The Food and Drug Administration (FDA) is responsible for assuring that medical devices are safe and effective before they go on the market. As part of its assessment of FDA's premarket clearance process for medical devices, the IOM held a workshop June 14-15 to discuss how to best balance patient safety and technological innovation. This document summarizes the workshop.
Publisher: National Academies Press
ISBN: 0309162904
Category : Medical
Languages : en
Pages : 141
Book Description
The Food and Drug Administration (FDA) is responsible for assuring that medical devices are safe and effective before they go on the market. As part of its assessment of FDA's premarket clearance process for medical devices, the IOM held a workshop June 14-15 to discuss how to best balance patient safety and technological innovation. This document summarizes the workshop.
FDA Biotechnology Inspection Guide
Author: United States. Food and Drug Administration
Publisher:
ISBN:
Category : Biotechnology
Languages : en
Pages : 62
Book Description
Publisher:
ISBN:
Category : Biotechnology
Languages : en
Pages : 62
Book Description
In Vitro Diagnostic Devices
Author:
Publisher:
ISBN:
Category : Medical instruments and apparatus
Languages : en
Pages : 66
Book Description
Publisher:
ISBN:
Category : Medical instruments and apparatus
Languages : en
Pages : 66
Book Description
Dietary Supplements
Author: United States. Federal Trade Commission. Bureau of Consumer Protection
Publisher:
ISBN:
Category : Advertising
Languages : en
Pages : 32
Book Description
Publisher:
ISBN:
Category : Advertising
Languages : en
Pages : 32
Book Description
Biodesign
Author: Stefanos Zenios
Publisher: Cambridge University Press
ISBN: 0521517427
Category : Medical
Languages : en
Pages : 779
Book Description
Recognize market opportunities, master the design process, and develop business acumen with this 'how-to' guide to medical technology innovation. Outlining a systematic, proven approach for innovation - identify, invent, implement - and integrating medical, engineering, and business challenges with real-world case studies, this book provides a practical guide for students and professionals.
Publisher: Cambridge University Press
ISBN: 0521517427
Category : Medical
Languages : en
Pages : 779
Book Description
Recognize market opportunities, master the design process, and develop business acumen with this 'how-to' guide to medical technology innovation. Outlining a systematic, proven approach for innovation - identify, invent, implement - and integrating medical, engineering, and business challenges with real-world case studies, this book provides a practical guide for students and professionals.
Medical Device Regulations
Author: Michael Cheng
Publisher: World Health Organization
ISBN: 9241546182
Category : Medical
Languages : en
Pages : 54
Book Description
The term 'medical devices' covers a wide range of equipment essential for patient care at every level of the health service, whether at the bedside, at a health clinic or in a large specialised hospital. Yet many countries lack access to high-quality devices, particularly in developing countries where health technology assessments are rare and there is a lack of regulatory controls to prevent the use of substandard devices. This publication provides a guidance framework for countries wishing to create or modify their own regulatory systems for medical devices, based on best practice experience in other countries. Issues highlighted include: the need for harmonised regulations; and the adoption, where appropriate, of device approvals of advanced regulatory systems to avoid an unnecessary drain on scarce resources. These approaches allow emphasis to be placed on locally-assessed needs, including vendor and device registration, training and surveillance and information exchange systems.
Publisher: World Health Organization
ISBN: 9241546182
Category : Medical
Languages : en
Pages : 54
Book Description
The term 'medical devices' covers a wide range of equipment essential for patient care at every level of the health service, whether at the bedside, at a health clinic or in a large specialised hospital. Yet many countries lack access to high-quality devices, particularly in developing countries where health technology assessments are rare and there is a lack of regulatory controls to prevent the use of substandard devices. This publication provides a guidance framework for countries wishing to create or modify their own regulatory systems for medical devices, based on best practice experience in other countries. Issues highlighted include: the need for harmonised regulations; and the adoption, where appropriate, of device approvals of advanced regulatory systems to avoid an unnecessary drain on scarce resources. These approaches allow emphasis to be placed on locally-assessed needs, including vendor and device registration, training and surveillance and information exchange systems.