NSF International offers online learning for MDSAP program

July 27, 2018 / by Kapstone Medical posted in 510(k), medical device, Quality

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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).

FDA’s Strategic Policy Roadmap for 2018

April 25, 2018 / by Kapstone Medical posted in 510(k), FDA, medical devices

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FDA Commissioner aims to streamline review and beef up technical support

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

November 13, 2015 / by Kapstone Medical posted in 3d print, 3D Printing, 3d prosthetics, 510(k), Additive Manufacturing, FDA, FDA 510(k), FDA approval, FDA clearance, innovators, inventors, kapstone medical, manufacturing, medical device, medical device inventors, medical devices, medtech, Monthly Round-Up, orthopaedic, Orthopedic, orthopedics, physician inventors, Product Development, surgeons, what you missed last month

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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!

What You Missed Last Month (Apr 2015 Edition)

May 2, 2015 / by Kapstone Medical posted in 3D Printing, 3d prosthetics, 510(k), FDA, FDA 510(k), FDA approval, innovators, inventors, medical device, medical device inventors, medical devices, Monthly Round-Up, orthopedics, physician inventors, prosthetics, surgeons, what you missed last month

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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:

What You Missed Last Month (Mar 2015 Edition)

April 17, 2015 / by Kapstone Medical posted in 3D Printing, 510(k), FDA, FDA 510(k), FDA clearance, innovators, inventors, medical device, medical device inventors, medical devices, Monthly Round-Up, prototyping, surgeons, what you missed last month

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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:

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.

An Integrated vs. Piecemeal Approach to Product Development

December 4, 2014 / by Stuart Lindquist posted in 510(k), FDA, inventors, medical device, physician inventors, Product Development, prototyping, realize your idea, Regulatory affairs, surgeons

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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...

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

September 26, 2014 / by admin posted in 510(k), FDA, innovators, inventors, medical device, orthopedics, physician inventors, Product Development, protect your idea, prototyping, realize your idea, surgeons

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When and how to get constructive feedback throughout the development process

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

September 26, 2014 / by John Kapitan posted in 510(k), FDA, innovators, intellectual property strategy, inventors, IP fit, medical device, orthopedics, physician inventors, Product Development, prototyping, realize your idea, Regulatory affairs, surgeons

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The Top Ten Things to Avoid

Making the Case for Industrial Design and Human Factors

August 27, 2014 / by Ryan Lewis posted in 510(k), FDA, IP fit, manufacturing, Product Development, prototyping, Regulatory affairs

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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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