International Labeling Requirements for Medical Devices, Medical Equipment and Diagnostic Products: 2nd Edition (Hardback) book cover

International Labeling Requirements for Medical Devices, Medical Equipment and Diagnostic Products

2nd Edition

By Charles Sidebottom

CRC Press

616 pages

Purchasing Options:$ = USD
Hardback: 9780849318504
pub: 2003-06-27
SAVE ~$31.50
$210.00
$178.50
x
eBook (VitalSource) : 9780429205323
pub: 2003-06-27
from $28.98


FREE Standard Shipping!

Description

Completely revised, this second edition provides the practical, hands-on labeling information needed to secure rapid regulatory approval, gain marketplace acceptance, and assure user comprehension. A complete guide to all aspects of advertising, labeling, and packaging, it explains the relevant laws, regulations, and requirements in major markets worldwide and provides examples of compliance and noncompliance. Coverage includes requirements such as text, dimensions, type sizes, graphic elements, symbols, and language for implantable devices, sterile devices, over the counter products, in vitro diagnostic products, radiation emitting devices, contraceptive devices, and more.

Reviews

…an asset to the medical device industrycontinues to provide practical guidance for industry to facilitate international regulatory approvals and appropriately educate users in today's environment… - From the foreword by Charles H. Swanson, Ph.D., Vice President and Chief Regulatory Officer, Medtronic, Inc.

Promo Copy

Table of Contents

Completely revised, this second edition provides the practical, hands-on labeling information needed to secure rapid regulatory approval, gain marketplace acceptance, and assure user comprehension. A complete guide to all aspects of advertising, labeling, and packaging, it explains the relevant laws, regulations, and requirements in major markets worldwide and provides examples of compliance and noncompliance. Coverage includes requirements such as text, dimensions, type sizes, graphic elements, symbols, and language for implantable devices, sterile devices, over the counter products, in vitro diagnostic products, radiation emitting devices, contraceptive devices, and more.

Subject Categories

BISAC Subject Codes/Headings:
MED071000
MEDICAL / Pharmacology
TEC021000
TECHNOLOGY & ENGINEERING / Material Science