4 Questions to Ask Before Submitting a 510(k)

March 5, 2015 / by Kapstone Medical posted in 510(k), FDA, FDA approval, innovators, kapstone medical, medical devices, physician inventors, product development advice, realize your idea, Regulatory, Regulatory affairs, surgeons

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So you’re an inventor who wants to develop a medical device and use the invention in practice. You know the FDA regulates medical devices, but that’s about as far as your knowledge takes you.

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