The Certifications obtained by the company in the years, represent
its concrete intention and the strong will that since 1999 Adria.Med
pursues for the continuous improvement of quality and customer satisfaction.
The result of this is the quality and assurance of its medical devices
respecting the EEC 93/42 Directive and the achievement of ambitious
targets such as project and development of new devices and innovative
processes.The company also achieved a certification in 2005 for its
ethylene oxide sterilization process of its own production and third
party accounts that are sterilized within the factory in an ethylene
oxide that has been convalidated according to EN 550 and ISO 11135
norms.
The areas in which we apply quality management in Adria.Med, according
to UNI EN ISO 9001 and ISO 13485, regard the following: project work,
development, production of pouches in PVC for non sterile medical
use, infusion and transfusion sets, particular infusion lines, extensions,
, sterile extension tubes, tubes, sterile instruments and accessories
for ophthalmic surgery, sterile kits for ophthalmic surgery areas,
sterile disposable gloves, non sterile plastic components for medical
use, sterilization for in house and third party products. The production
of medical devices is in the hands of competent trained staff that
work in a particle contaminated and micro biologically controlled
area (white room class ISO 8 according to UNI EN ISO 14644).
The white rooms in the factory have a total surface
of 350 sqm and are over pressured in comparison to the adjoining areas.
They undergo periodical particle and micro biological tests to verify
their constant conformity to the ISO 8 class norm. The types of control
for conformity range from dimensional, visual, functional, technological,
chemical and biological tests which are performed by qualified staff
and advanced equipment which in turn also undergoes periodical check
ups.
The post sales surveillance performed by the company
in the post production phase, guarantees an up to date data base on
quality which allows it to perform actions of prevention and correction
finalized towards company improvement.
