New professional society journal article reviews contemporary global best practices on product safety.
NATICK, MA – July 1, 2007 – Clinivation, Inc. announced today the publication of a new professional society journal article coauthored by clinivation thought leaders in the areas of product safety, postmarket surveillance, risk management, and regulatory affairs.
The article entitled “Medical Device Design Assurance: Contemporary Global Best Practices in Product Safety” is published in the July, 2007 edition of the Regulatory Affairs Professional Society journal Regulatory Affairs Focus.
The article addresses medical device design assurance, including clinical approaches to safety signal detection and validation. It also reviews the best practices in quantitative decision making, human factors engineering, inductive and deductive fault tree analysis, and postmarket approaches to safety signal detection.
The article is coauthored by clinivation Founder and CEO Joseph Kozikowski, M.D. and Richard Morroney, RAC, CQA, Vice President, Quality & Regulatory Solutions, clinivation, Inc.
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