It’s tough for medical device companies to get that stamp of FDA approval, but the labyrinthine regulatory pathway certainly doesn’t help things. Regulators want to change that: “…we learned that the delivery of new therapies to patients can be accelerated if medical device innovators — including entrepreneurs and university students and faculty — understand FDA’s regulatory processes,” FDA researcher Francis Kalush wrote recently. She blogged about the administration’s “National Medical Device Curriculum” - a free regulatory training program geared largely toward “small companies that may not have the expertise to navigate FDA’s requirements.”
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