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

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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”

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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)

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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

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