5205198800_afbc523eb7_b

FDA lists proposed guidance publications for 2019

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.

Read More...
additive-manufacturing-medical-device-regulation

What You Missed Last Month September

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...

Read More...
FDA-Image.png

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

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...

Read More...
Blausen_0618_LumbarSpine11.jpg

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

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...

Read More...
sample_image.jpg

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

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,...

Read More...
A_surgical_operation_total_knee_replacement._Drawing_by_Vir_Wellcome_L0028360.jpg

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

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...

Read More...
Dollarphotoclub_64908601-600x400.jpg

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.

Read More...