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SOOFT Italia has been awarded two important quality certifications: UNI EN ISO 9001:2008 and UNI EN ISO 13485 issued by the Accredited Certification Body Certiquality.
The Certification UNI EN ISO 9001:2008 attests the full respect of the standards set up and published by the International Standardization Organization (ISO) in terms of quality management systems. UNI EN ISO 13485 is a more specific certification. It certifies that SOOFT Italia has a quality manufacturing process for medical devices and has a management standards in place to maintain that quality.
The achievement of the certifications confirms the OOGroup firm commitment towards everyday higher qualitative standards. |
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On Friday November 25th, during the 90th SOI (Italian Ophthalmologists Society) meeting held in Milan, the OOgroup won the Research and Innovation award, this prize is assigned by the Society every year to the Company that more than others has been active and successful in the research of innovative solutions for eye problems and well being . |
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Sooft Italia has struck a deal with its partner Company OOX, already involved with the logistics organization of the OO Group, for capsules and tablets blistering and packaging activities. The localization of this kind of activity in a facility next to the main Company building allows the OO Group to operate with better flexibility and efficiency. |
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Sooft Italia products used in international Cross-Linking Trials |
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During the last American Academy of Ophthalmology (AAO) meeting held in Chicago in October, Sooft Italia co-sponsored with Topcon an educational symposium entitled: “New Therapeutic and Diagnostic Technologies for the Anterior Segment”.
The main topics included the results from physician-sponsored U.S. clinical trials, cross-linking in children and trans-epithelial cross linking.
A multi-center clinical study run by Topcon is taking place at 10 sites across the US, with the aim to evaluate the results of treatment in 240 patients with keratoconus or corneal ectasia.
In the cross-linking treatment, the cornea is saturated with riboflavin (Ricrolin, SOOFT Italia) and then exposed to ultraviolet light with riboflavin (VEGA, Sooft Italia). |
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RICROLIN® is an ophthalmic solution of riboflavin |
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RICROLIN® is a 0.1% ophthalmic solution of riboflavin (vitamin B2), manufactured and distributed exclusively throughout the world by SOOFT Italia S.p.A., and which will be on the market from late April 2007.
RICROLIN® has been registered by the General Medical Council as a medical device, and approved with CE certification. It is delivered in a throw-away, sterile dispenser. RICROLIN® is used for cornea collagen cross-linking para-surgical operations involving cornea complaints associated with a UV-A source. The main purpose of RICROLIN® is to provide a protective barrier against penetration by UV-A rays across the corneal stroma, thus maintaining the delicate structures inside the eye (corneal endothelium, lens, and retina). RICROLIN® solutions can reduce UV energy intensity by as much as 95% at the deeper layers of the cornea. |
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Cornea collagen cross-linking para-surgical operations involving cornea complaints, as well as RICROLIN® (riboflavin), require the use of a UV-A source to provide photo-polymerisation of corneal collagen. VEGA CBM X-LINKER®, made by the manufacturers of ophthalmic instruments CSO S.r.l. in Florence and distributed exclusively throughout the world by SOOFT Italia S.p.A., is a UV-A source (peak wavelength 370 nm) with great homogeneity and constancy over the irradiated area (up to a diameter of 11 mm) throughout the irradiation, with regard to the physical safety parameters seen during tests.
The VEGA CBM X-LINKER® has a 5.6-in LCD control screen, providing important guidance for the user especially during the operating stage. There is a pedal-operated switch to turn it on and off and keep it sterile when there is an operator (so additional personnel are not required), and adjustable head and arms, co-axial lighting for the camera so that the patient finds it easier to align his eye along the UV-A beam shining onto his cornea (two flashing LEDs), an integrated colour camera for control in real time, using the LCD monitor, of centring of the irradiated area and proper alignment of the two LEDs. |
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Eyes and Diabetes" Conference, Fermo, 18 - 19 September 2008 |
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| In 2008, OOgroup will be sponsoring once again an OPHTHALMOLOGY conference in Fermo, and this time it will examine eye diseases caused by diabetes.
The conference will be held at the Dell’Aquila theatre in Fermo, from 18 to 10 September. Some of the best minds from Italy and around the world will be taking part.
In recent years (www.fermocongressi.org) the main topics have been dry eye and macular degeneration, which were great successes in terms of content and participation. |
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17 September 2007: head office “re-inauguration” |
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After four months of trouble and strife, worry and hard work, our head office was re-inaugurated on 17 September. It had been almost totally destroyed on 11 May 2007 when a nearby fireworks factory exploded. Special thanks are due to all the companies who were able to complete work in such a short space of time, some of them even giving up their summer holidays, and to everyone at OO who made his little miracle possible. |
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The photo shows an olive tree given by staff at OO Head Office as a symbol of rebirth, vitality, and tenacity. |
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18 July 2007: the launch of Sooft Italia S.p.A. |
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On 18 July 2007, a special shareholders' meeting voted to change the legal status of the Company from limited liability to public limited company, and to raise share capital from one hundred thousand euros (€100,000) to one million euros (€1,000,000).This operation is part of an overall tidying-up strategy within the OO group, and a strengthening of Sooft Italia from an asset and financial point of view. The public limited company is the most important type in the current Italian situation, and is the preferred form for medium to large-size businesses. This transformation, from a legal point of view, will bring Sooft into line with company development requirements and the growth potential which the group is looking for. |
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