Home Standards and Regulations

Standards and Regulations

Be up-to-date with the new regulations in the 3D Printing and POC industry

The regulatory requirements of 3D printing medical devices at the hospital

Taking into consideration all the regularities that the hospital has to get through before beginning to print out the devices, it’s important...

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...

A Custom-Made Medical Device manufacturing

With the development of 3D printing, custom-made devices are becoming widely implemented. Enabling unlimited personalized solutions, their manufacturing and usage are...

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...