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The high costs of noncompliance

Industry News, Education, FDA, Regulatory

The US medical device market was valued at $127B in 2013 making it the largest in the world.

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Manufacturing Group February 3, 2014

Tolland, Conn. - Even with the stats of the global and U.S. medical market value today, millions of dollars are lost every year due to regulatory noncompliance issues and related lawsuits.

Nerac's regulatory team helps medical device manufacturers accelerate regulatory approval for new product introductions and monitor the clinical performance of their products.

Regulatory analysts offer specific expertise in clinical literature evaluations, technical file reviews and updates, gap analysis and risk assessment of compliance with the MDD essential requirements. Nerac also offers post-market literature evaluations and ongoing surveillance for product safety to maintain compliance throughout the product lifecycle.

Download the recent article, "The Costs of Regulatory Noncompliance in the Medical Device Industry: Is it Worth the Gamble?" by Nerac Analyst Donna Mitchell-Magaldi, that takes a closer look at some of the current lawsuits that have resulted from quality issues and which clearly demonstrates that the costs of noncompliance are high.

Source: Nerac

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