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FDAnews Device Daily Bulletin
Oct. 24, 2012 | Vol. 9 No. 209
New ISO Anti-Counterfeit Standard Strengthens Product Verification Processes
In response to the rapid rise in counterfeits, the International Organization for Standardization (ISO) has issued a new industrywide standard to help ensure the life-cycle integrity of products. While not a cure-all or substitute for track-and-trace programs, ISO 12931:2012 assists devicemakers in defining and generating risk-based, user-defined authentication elements for integrating into products and packaging.
International Medical Device Regulatory Monitor
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