NSF International offers online learning for MDSAP program

July 27, 2018 / by Kapstone Medical / 1 minute read

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 device industry in the five countries participating in Medical Device Single Audit Program (MDSAP).

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FDA’s Strategic Policy Roadmap for 2018

April 25, 2018 / by Kapstone Medical / 2 minute read

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)

November 13, 2015 / by Kapstone Medical / 2 minute read

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)

May 2, 2015 / by Kapstone Medical / 2 minute read

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, biomedical, and 3D printing communities. Read on for what you may have missed last month:

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What You Missed Last Month (Mar 2015 Edition)

April 17, 2015 / by Kapstone Medical / 2 minute read

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)

March 5, 2015 / by Kapstone Medical / 2 minute read

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

December 4, 2014 / by Stuart Lindquist / 0 minute read

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, regardless of how far you plan to go. Read More...

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

September 26, 2014 / by admin / 0 minute read

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)

September 26, 2014 / by John Kapitan / 0 minute read

The Top Ten Things to Avoid

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Making the Case for Industrial Design and Human Factors

August 27, 2014 / by Ryan Lewis / 0 minute read

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 physicians on the front lines of medical practice. How can ideas be harnessed for the benefit of patients and physicians? Read More...

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