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NSF International offers online learning for MDSAP program

The National Sanitation Foundation (NSF) has produced a series of online training courses for regulatory compliance officers and auditors involved with regulatory processes working in the medical...

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FDA’s Strategic Policy Roadmap for 2018

FDA Commissioner aims to streamline review and beef up technical support

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What You Missed Last Month (October 2015 – Medical Devices & 3D Printing)

Happy November! Fall is finally here, and with the cascading leaves also descends a plethora of exciting developments emanating from the world of Medical Devices and 3D Printing!

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What You Missed Last Month (Apr 2015 Edition)

It’s time to catch up, and Kapstone Medical is ready to equip and guide you through the month of April 2015 with some of the most interesting, engaging, and inspiring news from the FDA,...

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What You Missed Last Month (Mar 2015 Edition)

Welcome to the latest round of Kapstone Medical’s “What You Missed Last Month” in the Medical Device industry. Here’s what you missed in Med Device and 3D Printing industry for the month of March:

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4 Questions to Ask Before Submitting a 510(k)

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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An Integrated vs. Piecemeal Approach to Product Development

In this article, I’d like to focus on another important aspect of maximizing the value of your idea—the need to consider and integrate all aspects of product development from the very onset,...

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Roadmap to Success...Does Your Design Need a Second Opinion?

When and how to get constructive feedback throughout the development process

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A Roadmap to Success for Surgeon Inventors, Part 5 (installment 2)

The Top Ten Things to Avoid

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Making the Case for Industrial Design and Human Factors

An all too familiar dilemma: a physician has a great idea, but can only take it so far. A new device, a change to a procedure, a way to save time in the OR; medical technology is driven by...

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