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Useful summaries of information on international regulations and standards.

Articles

bullet IVD Directive - A Quick Reference Guide
bullet ISO - Overview
Regulations and Standards

Pertinent Global Advisor Newsletter Articles:

bullet The In-Vitro Diagnostics Directive (IVDD)
bullet The U.S. Medical Device Regulatory System
bullet Classification of Medical Devices
bullet Glossary of Related Terms

Related links

bullet European Union Web Site
bullet Medical Device Regulation - FDA Site
bullet The European Chemicals Bureau (ECB)

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