What Quality Assurance does DESS provide?
All of our parts are within a 10 to 20 micron accuracy.
Every batch of components goes through a series of measurement and quality control inspections to ensure that the geometry, tolerance, and fit of the manufactured part match the original CAD dimensions. This is done using two types of measurement/metrology systems (Reinshaw touch probe and optical/vision system). The part is measured in multiple locations and every section has to pass in order to be acceptable to move onto visual inspections.
Each component is then inspected visually following the ISO rules to assure quality.
Since 2008, we have a sanitary department with our own clean room and backed by our CE and ISO 13485 certification. Our entire manufacturing process is regulated under the EU Medical Directive 93/42/CEE (as amended by Directive 2007/47/CE). The process follows ISO 9001:2008 & ISO 13485:2012 and it is yearly audited by the Notified Body.
All our titanium is ASTM-F136 certified from a European supplier.
DESS has both CE and Health Canada approval.
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