Tuesday, February 08, 2011 10:53 AM
TPLC: Is Industry Ready to Meet CDRH's Top Strategic Priority?
By Daniel R. Matlis
Total product lifecycle management must become more than an FDA-, compliance-focused initiative. To reap the cost, quality and regulatory benefits presented by TPLC, companies must adopt new ways of conducting business. With consistently applied processes and systems, companies will be able to predict and prevent quality issues that affect compliance and cost.
On January 19, 2011, FDA’s Center for Devices and Radiological Health (CDRH) released its 2011 Strategic Priorities. On the top of the list: Fully implement a Total Product Life Cycle (TPLC) approach . To determine the industry’s adoption of the Total Product Life Cycle (TPLC) approach advocated by FDA, we conducted a research study. The research findings show that while the vast majority of medical device organizations are rolling out key initiatives aimed at supporting TPLC, most more...
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