ADDMAN Group has enhanced its ISO 13485 certification with the combination of two 3D Techniques ProX DMP 320 3D printing methods.
The corporate, a complicated manufacturing service supplier, believes the enhancement of the ISO 13485 certification will bolster its place within the medical manufacturing business.
ADDMAN Group is made up of a number of acquired companies together with CASTHEON, Dinsmore and HARBEC, with the acquisitions made to construct out a complete providing of additive engineering and manufacturing options and providers.
Previous to this assortment of takeovers, ADDMAN achieved its preliminary ISO 13485 certification in 2016, however has continued to search for methods to enhance its providing to the healthcare sector. That has led the corporate to the acquisition of two 3D Techniques 320 3D printers, with ADDMAN suggesting the machines will assist to diversify its manufacturing capabilities and ship complete options to the medical system sector.
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3D Techniques’ ProX DMP 320 machines are geared up with 275 x 275 x 420 mm construct volumes, whereas in a position to obtain a most layer decision of 30 micron. The machines are supported by the 3DXpert ‘all-in-one’ additive manufacturing software program answer and have an intensive vary of pre-developed parameters.
As ADDMAN has introduced these machines on board, it has expanded its ISO 13485:2016 certification for high quality administration methods within the medical system business. This implies the corporate is able to assembly regulatory and buyer necessities, with the certification confirming ADDMAN has a strong high quality administration system (QMS) framework. This QMS will assist ADDMAN meet the excessive precision and consistency necessities of the medical business, whereas additionally making certain medical units produced by the corporate meet stringent security and efficiency requirements. The usual additionally signifies compliance with international regulatory requirements, which is crucial for participation within the worldwide medical system market.
