GIESSE TECHNOLOGY
Has successfully started up and completed, the CE marking in accordance of its Medical Devices in accordance with Directives and EU Regulations.
The developed products, studies, tests, manufacturing and customer assistance are regulated and monitored by a certified Quality System according to ISO 13485-2016 for medical components by TÜV Rheinland and are entirely made in GIESSE TECHNOLOGY without the presence of external suppliers except for the sterilization process.
The continuous attention that GiEsse Technology has towards the quality of its products is testified by constant laboratory tests and analyses, conducted to verify their safety towards patients and the ability to achieve the declared performances.
To carry out these tests, GiEsse Technology avails itself of the collaboration of prestigious University Research Centers, such as the scientific-technological university Politecnico Milano and the University of Trieste, as well as laboratories adopting a certified Quality Management System for the execution of technical consultancy services in the biomedical field and laboratory services for microbiologicaò and physical analyses.
Tests and analyses are conducted according to the European standards (EN standards) and iternational standards (ISO standards), and according to the FDA (Food and Drug Administration) guidelines, in order to demonstrate the compliance of the products with the highest safety and performance standards.