Medical device regulations : global overview and guiding principles.

Medical devices and equipment are a vital component of patient care. From a simple tongue depressor to a sophisticated haemodialysis machine, medical devices are needed at every level of the health service. Yet many health services continue to lack information and financial resources to acquire the...

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Bibliographic Details
Call Number:Libro Electrónico
Main Author: Cheng, Michael
Corporate Author: World Health Organization
Format: Electronic eBook
Language:Inglés
Published: Geneva : World Health Organization, ©2003.
Subjects:
Medical instruments and apparatus > Standards.
Risk management.
Quality control.
International cooperation.
Equipment and Supplies > standards
Equipment Safety > standards
Device Approval > legislation & jurisprudence
Device Approval > standards
Health Policy > legislation & jurisprudence
Policy Making
Risk Management
Quality Control
International Cooperation
Gestion du risque.
Qualité > Contrôle.
Coopération internationale.
risk management.
quality control.
MEDICAL > Instruments & Supplies.
Risk management
Quality control
International cooperation
Medical instruments and apparatus > Standards
Online Access:Texto completo
Table of Contents:
  • Foreword; Glossary; Chapter 1. Introduction; Chapter 2. Medical device safety; Chapter 3. Governmental regulation of medical devices; Chapter 4. Global Harmonization Task Force (GHTF); Chapter 5. Standards; Chapter 6. Optimizing the use of regulatory resources; Chapter 7. Priorities on the international agenda; Annex 1. Resources for medical device information; Annex 2. Final documents of the GHTF as they relate to the Common Regulatory Framework; Annex 3. Relationship between ISO9001:1994 and ISO13485:1996; Annex 4. Aide-mémoire for National Medical Device Administrations.

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