Category Archives: Blog content

So We’re All on the Same Page: You Need a Test Plan

I’m a huge fan of lists. Covering every base with an organized way to track everything from my companies’ financial progress to whether the Doritos made it into the car for the drive home from school keeps me functioning. I note things on my computer, tablet, smartphone, spiral paper planner, and a series of Post-it…
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Pro Tips for Prototypes: The Smart Way to Manage Device Iterations

There’s something about hitting the prototype stage of the development cycle that makes everything finally seem real. This is the point at which there is finally an object to hold in your hands—a physical representation of the vision, investment, and commitment a medical device developer has to improving patient lives. Read more in MPO Magazine...
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Mock Trial: Outsourcing to Prepare for Your Class III Premarket Panel

For a company navigating a Class III medical device’s path to market, the U.S. Food and Drug Administration (FDA) panel presentation is the make-or-break point. That’s the day to present a case to convince the FDA that the device—for which there’s no comparable predecessor—is safe and effective enough to be used on patients. Read more…
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