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New regulation of MDR 2017/745 postponed to 26th of May 2021

The Medical Devices Regulation (MDR) (EU) 2017/745 prepared by The Council and the European Parliament and enforced in May 2017 was...

Webinar about “3D printing at Point-of-Care”

On 23rd of June, Fusedbone and Kumovis company hosted a webinar about “3D printing at Point-of-Care” industry. The topics covered in the...

FDA guidelines for 3D printed medical devices (part I)

As the FDA is the main organ responsible for approval of 3D printed medical devices, it developed specific, technical considerations of additive...

The challenge of the hospital to become a 3D Point-Of-Care manufacturer

The main challenge for the hospital to become a medical device manufacturer is setting up a 3D printing lab. However,  it doesn’t...