New professional society journal article a maturity model for transforming organizations within the context of medical device risk management.
NATICK, MA – June 30, 2010 – Clinivation, Inc. announced today the publication of a new professional society journal article coauthored by clinivation thought leaders in the areas of medical device product risk management, organizational transformation, and regulatory affairs.
The article entitled “Medical Device Risk Management Maturity Model” is published in the July, 2010 edition of the Regulatory Affairs Professional Society journal Regulatory Affairs Focus.
The article addresses the need for effective product risk management to ensure product safety in the medical device industry.
The article also presents the Medical Device Risk Management Maturity Model, developed by clinivation Founder and CEO Joseph Kozikowski, M.D. and clinivation thought leaders.
As described in the article, the Medical Device Risk Management Maturity Model is designed to meet multiple objectives:
- To describe the maturity state of those attributes most critical to an organization’s ability to achieve an effective risk management process: risk management planning and responsibility, risk assessment, risk control discipline, risk management process management and integration, risk management reporting, risk benefit management, risk management file;
- To provide a common language for cross-organizational communication and benchmarking;
- To guide risk management improvement efforts with a framework that helps organizations establish and achieve improvement goals; and
- To provide specific guidance to leaders in executive, risk management, regulatory and commercial roles regarding which specific practices to perform, how to improve the ability to perform those practices and how to prioritize areas targeted for improvement.
The article is authored by Richard Morroney, RAC, CQA, Vice President, Quality & Regulatory Solutions, clinivation, Inc.
Quotes & Commentary:
“Maturity models are very important tools organizational transformations,” said clinivation Founder and CEO Joseph Kozikowski, M.D. “Maturity models demonstrate how software platforms enable organizations to evolve from states of noncompliance, poor risk management, and opacity to states of operational excellence,” he continued.
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