ADDMAN Group has enhanced its ISO 13485 certification with the integration of two 3D Systems ProX DMP 320 3D printing systems.
The company, an advanced manufacturing service provider, believes the enhancement of the ISO 13485 certification will bolster its position in the medical manufacturing industry.
ADDMAN Group is made up of several acquired businesses including CASTHEON, Dinsmore and HARBEC, with the acquisitions made to build out a comprehensive offering of additive engineering and manufacturing solutions and services.
Prior to this collection of takeovers, ADDMAN achieved its initial ISO 13485 certification in 2016, but has continued to look for ways to improve its offering to the healthcare sector. That has led the company to the purchase of two 3D Systems 320 3D printers, with ADDMAN suggesting the machines will help to diversify its manufacturing capabilities and deliver comprehensive solutions to the medical device sector.
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3D Systems’ ProX DMP 320 machines are equipped with 275 x 275 x 420 mm build volumes, while able to achieve a maximum layer resolution of 30 micron. The machines are supported by the 3DXpert ‘all-in-one’ additive manufacturing software solution and have an extensive range of pre-developed parameters.
As ADDMAN has brought these machines on board, it has expanded its ISO 13485:2016 certification for quality management systems in the medical device industry. This means the company is capable of meeting regulatory and customer requirements, with the certification confirming ADDMAN has a robust quality management system (QMS) framework. This QMS will help ADDMAN meet the high precision and consistency requirements of the medical industry, while also ensuring medical devices produced by the company meet stringent safety and performance standards. The standard also signifies compliance with global regulatory standards, which is critical for participation in the international medical device market.
