European MDR: Notified Bodies

December 4, 2019 / by Kapstone Medical / 3 minute read

Part 3 in our 7-part series on meeting the new requirements under the EU MDR

If you are new to obtaining marketing approval in the European Union, the concept of Notified Bodies is one of the most significant differences from the US FDA system or regulatory oversight.

A Notified Body is an independent certification organization that is “notified” by an EU member state’s Competent Authority, usually the ministry of health, to certify that a product meets the applicable requirements for CE marking.

Read More

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

July 10, 2015 / by Kapstone Medical / 2 minute read

Each month, as our team digs through the array of medical device, 3D printing, and orthopedics stories on the web, a theme seems to emerge and dominate the MedTech headlines. Throughout June 2015, the most-read stories surrounded 3D printing of tissues and 3D printing’s overall potential in healthcare, now and beyond.

Read More

Subscribe for the Latest News


See all