Reference Library--Some Useful Links...

Regulatory...
Quality...

Law...

ISO...

Medical...

Project/Materials Management...

Process Validation

News...

Research tools
 

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Regulatory...

Global Harmonization Task Force
Guidelines for Regulatory Auditing of Quality Systems of Medical Device Manufacturers
DESIGN CONTROL GUIDANCE FOR MEDICAL DEVICE MANUFACTURERS(11 Mar 97)
FDA Blue Book
FDA INVESTIGATIONS OPERATIONS MANUAL
FDA INSPECTION GUIDES
FDA FOREIGN INSPECTION MANUAL AND TRAVEL GUIDE
FDA Office of Regulatory Affairs Compliance References
Fedworld
Fedworld FTP Site
FDA Home Page
Regulatory Affairs Professionals Society (RAPS)
Medical Devices Agency (MDA){UK}
FDA Documents--Limited List
General Index of CDRH Documents
Code of Federal Regulations (CFR)
NEMA
HIMA
EUCOMED
USP
Government Printing Office (GPO) access
Purdue Government Printing Office (GPO) access
NIH (National Institute of Health)
Centers for Disease Control and Prevention (CDC)
The Regulatory Forum Home Page
FDLI
 
 

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Quality...

NIST Quality Program
American Productivity & Quality Center
IEEE Home Page
ASQC
Quality Resources Online
Qualinet
Quality Network
ANSI
NIST
Automotive Industry Action Group (AIAG)
NASA Quality Pages
Juran Institute
Deming Electronic Network
TQM Library
Society of Manufacturing Engineers
Continuous Quality Improvement Sources
Order QS-9000 (Quality System Requirements) Note: good & inexpensive source for ISO regs
Quality Documents Source
Public Sector Continuous Improvement Library
Design for Competitive Advantage
DoD Quality Management on-line library
General Business Information Source
Quality Manuals
ATT CIC Quality Manual
NET WORK SYSTEMS
Brookhaven National Laboratory Quality Manual

 
 

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Project/Materials Management...

Project Management
Project Management Research Sites
Project Risk Management
Distribution Logistics Library
Naval Logistics Library
LogLink - Transportation and Logistics Links
NEW ENGLAND SUPPLIERS INSTITUTE
National Center for Manufacturing Sciences
Materials Management/Just-In-Time Sources
Purchasing Sources
Decision Process Guidebook
 
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Process Validation....

GUIDELINE ON GENERAL PRINCIPLES OF PROCESS VALIDATION
GHTF Draft Process Validation Guidance
Best Manufacturing Practices
QSR Manual--Process Validation
 

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Law...

Library of Congress Home Page
FDLI
Congressional Gopher
Senate Gopher
White House Home Page
Thomas
Technology Law
Ethical Decision Making
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Medical...

U.S. Pharmacopeia
Medical Products Guide
The Merck Manual
Bio-sciences--Medicine
MEDMarket
Medical Informatics Links Alternate Site
Medical Reference Library
DHHS Consumer Health Reference
International Medical Resources
The Virtual Medical Center
Yale Medical Library--Selected Internet Resources in Bio-Medicine
Selected Medical References
 

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News...

Industry
Harvard Business Review
NewsPage-Healthcare
Medical Device Link
MDDI Article Index by Category
MDDI Article Index by Issue Date
Medical News--Newspage
Medical News--avicenna
Bio Online: Life on the 'Net
BioSpace Home Page
The Biotech Rumor Mill
PR Newswire--HealthCare
US Gov
 
Economic Statistics Briefing Room
Social Statistics Briefing Room
United States Information Agency
General
 
The Washington Post
San Francisco Chronicle/Examiner
Reuters News Summary
CNN Interactive
The New York Times
San Jose Mercury News
Singapore Straits Times
London Electronic Telegraph
NEWS RESOURCE

 
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ISO...

 

ISO 9000/QS-9000/ISO 14000 Support Group
GUIDELINES FOR REGULATORY AUDITING OF QUALITY SYSTEMS OF MEDICAL DEVICE MANUFACTURERS
ISO-Quality Management and Corresponding General Aspects for Medical Devices
ISO Home Page
IASG SANCTIONED QS-9000 INTERPRETATIONS
QS 9000 IASG Interpretations
Frequently Asked Questions About ISO 9000 and Related Standards
ISO 14000--International Environmental Management Standard
Preparing for ISO 14000 By Leveraging Off From ISO 9000
ISO 14000 Building Blocks
ISO 14000:The proposed series of environmental standards promises to keep you busy.

 

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Research tools...

Free MEDLINE
National Technology Transfer Center (NASA) Home Page
Association of University Technology Managers *** AUTM ***
SciQuest --internet source for scientific products
Wall Street Research Net
Pharmaceutical Industry Domain
Health Resource Directory
San Diego Source
Society of Competitive Intelligence Professionals
 
 
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Last modified: 25 Feb 99