๐”– Bobbio Scriptorium
โœฆ   LIBER   โœฆ

Achieving a Continual State of Regulatory Readiness

โœ Scribed by Judith M. Perry-Ewald; Barbara M. Howell


Book ID
118098799
Publisher
John Wiley and Sons
Year
2004
Tongue
English
Weight
581 KB
Volume
26
Category
Article
ISSN
1062-2551

No coin nor oath required. For personal study only.


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Since 1984, the US Food and Drug Administration (FDA) has utilized the Medical Device Reporting system as a mechanism for reporting adverse incidents associated with the use of medical devices, including external defibrillators. The frequency and content of these reports prompted an FDA-conducted fi