عنوان
پدید آورنده
موضوع
رده
R856.6 .C545 2003eb
R856
.
6
.
C545
2003eb
کتابخانه
محل استقرار
0585492654
1280060573
6610060576
9240680950
9241546182
9780585492650
9781280060571
9786610060573
9789240680951
9789241546188
b788476
Medical device regulations :
[Book]
global overview and guiding principles.
Geneva :
World Health Organization,
©2003.
1 online resource (ix, 43 pages) :
illustrations
"Prepared under the principle authorship of Dr Michael Cheng"--Title page verso.
Includes bibliographical references (pages 37-39).
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.
0
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 devices they really need, i.e. those that will address the specific disease burden in their country. Effective implementation of a National Regulatory Authority is a first step towards the cost-effective management of medical devices that meet international quality and safety standards, throughout t.
Medical device regulations.
9241546182
Medical instruments and apparatus-- Standards.
Device Approval-- legislation & jurisprudence.
Device Approval-- standards.
Equipment and Supplies-- standards.
Equipment Safety-- standards.
Health Policy-- legislation & jurisprudence.
International Cooperation.
Policy Making.
Quality Control.
Risk Management.
MEDICAL-- Instruments & Supplies.
Medical instruments and apparatus-- Standards.
MED-- 108000
610
.
284/0218
22
R856
.
6
.
C545
2003eb
Cheng, Michael.
World Health Organization.
20201207020240.0
pn
مطالعه متن کتاب [Book]
Y
