Blogs

FDA lists proposed guidance publications for 2019

posted in FDA, medical devices, Regulatory by Kapstone Medical

The FDA issued its list of proposed guidance publications for 2019 on Oct. 5 as part of its agreement to speed approvals of medical devices in exchange for additional funding from industry.

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30 Oct, 18

What You Missed Last Month September

posted in 3D Printing, FDA, medical devices, Regulatory by Kapstone Medical

September was a busy month for the 3D printing industry. There has been new insight on additive manufacturing and how to handle the latest Medical Device Regulation, a woman’s collapsed ankle was..

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29 Oct, 18

FDA Sets Priorities for 2016: What Does It Mean for Medical Devices?

posted in Big Data, biocompatibility, FDA, medical devices, Regulatory by MedTech Momentum

It’s the year of Big Data, and FDA has slated several priorities for fiscal year 2016 to improve regulatory science and introduce revised data quality standards. From leveraging Big Data for..

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16 Mar, 16

What You Missed Last Month (August 2015 Edition –Medical Device & 3D Printing)

posted in 3d print, 3D Printing, 3d prosthetics, Additive Manufacturing, august, FDA, FDA 510(k), FDA approval, FDA clearance, first 3d printed pill, Intellectual Property, intellectual property strategy, jiminy, medical device, medical device inventors, medical devices, medtech, Monthly Round-Up, orthopediatrics, Orthopedic, orthopedic surgeons, orthopedic surgery, orthopedics, phototyping, physician inventors, Product Development, Regulatory, Regulatory affairs, spinal stenosis, what you missed last month by Kapstone Medical

It’s back to school with Team Kapstone! In August, we picked up educational and inspirational stories in 3D printing, medical device, and orthopedics. Here’s your August “What You Missed” reading..

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16 Sep, 15

What You Missed Last Month (July 2015 Edition –Medical Device & 3D Printing)

posted in 3d print, 3d printed, 3d printed titanium skull, 3D Printing, cervical spine, cervical spine surgery, congenital hydrocephalus, disc replacement, FDA, FDA clearance, han han, medical device, medical device inventors, medical devices, motion preservation, neurosurgery, orthopaedic, Orthopedic, osteofab, polymer implant, Product Development, Regulatory, skull reconstruction, spinal fusion, spine surgery, spinefab, surgeon, surgical implant, what you missed, what you missed blog, what you missed in july by Kapstone Medical

While you were enjoying your summer vacation, Team Kapstone compiled some of the best stories in 3D printing, medical devices, and orthopedics. Catch back up with three articles to Inspire, Equip,..

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12 Aug, 15

What You Missed Last Month (May 2015 Edition- Medical Device & 3D Printing)

posted in 3D Printing, Additive Manufacturing, FDA, FDA approval, FDA clearance, innovators, intellectual property strategy, inventors, IP fit, IP services, kapstone, kapstone medical, kneeEOS, medical device, medical device inventors, medical devices, medical emergency, medtech, Model Prints, Monthly Round-Up, Orthopedic, orthopedic surgeons, orthopedic surgery, orthopedics, physician inventors, Product Development, prototyping, Radiography, Regulatory, Regulatory affairs, spinal fusion, titanium implant, TKA, what you missed last month by Kapstone Medical

Additive manufacturing, or 3D Printing, is dominating spring medical device industry headlines, and at halfway through the year, it’s slated to be on the Top 5 list of Kapstone Medical’s most..

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10 Jun, 15

4 Questions to Ask Before Submitting a 510(k)

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

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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05 Mar, 15
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