Home Industry ADDMAN extends medical certification for metal 3D printing

ADDMAN extends medical certification for metal 3D printing

The American company ADDMAN is integrating two metal 3D printers from the manufacturer 3D Systems into its production. The contract manufacturer is thus also expanding the scope of its ISO 13485 certification for medical technology.

ADDMAN offers comprehensive engineering and manufacturing services with a focus on additive manufacturing technologies. With the integration of the 3D Systems ProX DMP 320 systems, the company aims to expand its offering for customers in the medical industry.

The 3D printers have an installation space of 275 x 275 x 420 mm and achieve a layer thickness of 30 micrometers. They are controlled via the 3DXpert software from 3D Systems. Depending on the application, ADDMAN uses the systems with different metal powders such as stainless steel, cobalt-chrome or titanium.

By extending its ISO 13485:2016 certification, ADDMAN now meets the highest quality standards specifically for the development and manufacture of medical devices. This includes requirements for testing and calibration procedures, change control, traceability and documentation.

The company has held the certification since 2016, and with the integration of 3D Systems printers, the scope has now been expanded to offer customers in the medical technology sector an even more comprehensive AM offering.

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