Strong Design Controls

Achieving and maintaining regulatory compliance is an imposing hurdle for many medical device manufacturers. Missteps and inefficiencies addressing FDA, ISO, and other regulatory directives can result in costly delays, warning letters, and even business closure. Today’s manufacturers must establish proper design controls to demonstrate devices are safe and effective for their intended uses. This requires a more connected approach to introduce new products to market. Read this white paper to see how product-centric QMS enables better design controls.

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Helping You Innovate to Change the World

Thermo Fisher
medtronic
Bio Rad