Navigating the US Regulatory Pathways

Many non-US medical device, diagnostic and pharmaceutical companies have products that would sell well in the United States, but they hesitate to enter the market. These companies market in many countries outside their home nation but don’t cross the US…

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Creating a Roadmap to Commercialization

In today’s medical world where FDA approval is uncertain and investors shy away from risky ventures, a clever invention with incremental advantages over the competition is not enough. Successful innovation must go further than invention to turn good ideas into…

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