Teltow August 31, 2005. As a development-orientated medical technology company, SOMATEX® Medical Technologies has now been certified according to EN ISO 13485:2003. For this process of certification, the entire company was assessed. Certification was completed one year before it becomes mandatory on July 31, 2006. The following processes were examined: strategic processes (e.g. business targets), core processes (e.g. development and manufacturing), supporting processes (e.g. corporate communication) and quality management/documentation.
The EN ISO 13485:2003 entitled "Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes" is a separate standard based on the widespread quality standard ISO 9001:2000, but it additionally covers the specific legal requirements for technical medical devices.
The extensive requirements of this standard have been successfully implemented in all divisions of the company. ”Due to the process-orientated approach of EN ISO 13485:2003 we can make our business processes even more transparent. We can thus optimize and monitor all processes in an easier and more efficient way,” says Agata Jaron of SOMATEX. The quality manager also underlines that little will change for SOMATEX® customers, ”because our internal quality requirements are usually stricter than what is required by EN ISO 13485.”
Information on SOMATEX®
The company SOMATEX® Medical Technologies GmbH specializes in the development and manufacturing of disposable minimally invasive instruments in the areas of tumor ablation, vertebroplasty, biopsy and oncology.
In addition to the manufacturing of standard instruments for diagnostic and therapeutical procedures, SOMATEX® develops innovative special products and new instruments based on what treating physicians precisely need. Since 1992, the company constantly develops new medical therapy concepts and realizes them in their products in close cooperation with physicians, hospitals and university clinics. Its focus is set on methods and instruments allowing minimally invasive operations using magnetic resonance imaging. In the past few years, the SOMATEX® has also intensified its activities aiming at the development of new procedures and instruments used to treat painful vertebral compression fractures, for example caused by osteoporosis.
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Press Contact
unlimited communications berlin
Mr. Torsten Krüger
Rosenthalerstr. 40/41
D-10178 Berlin
Tel. 030 / 280078-63
E-Mail: tkrueger@ucm.de
Contact SOMATEX
SOMATEX Medical Technologies GmbH
Ms. Anja Schlicht
Rheinstr. 7d
D-14513 Teltow
Tel +49 (0) 3328 / 30 76-12
E-Mail: a.schlicht@SOMATEX.com
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