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ISO 13485: yet another certification achieved by Orthofan

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28 June 2019


ORTHOFAN SRL CONSEGUE LA CERTIFICAZIONE ISO 13485: PRIMO LABORATORIO ORTODONTICO CERTIFICATO IN ABRUZZO (Fonte, UNO DEI POCHI IN ITALIA. Civitella del Tronto (TE), 28 June 2019 ORTHOFAN SRL announces that, following complex preparatory and preliminary activities that began in January 2018, it has obtained from DNV GL – a globally recognised certifying body – the UNI EN ISO 13485:2016 quality certificate for its Orthodontic Lab Villa Lempa (TE) where the activities of ‘Design and manufacture of customised individual orthodontic devices – design and delivery of training courses in the field of orthodontic technique’ are carried out. The certification includes the entire production and distribution chain, from raw material procurement, production, traceability, logistics, through to human resources management and contracts. ISO 13485 is in addition to the UNI EN ISO 9001 certification that Orthofan has already achieved and maintained brilliantly since 2006


“We are particularly proud to have obtained this certification, which will be of fundamental support to our Italian market consolidation and internationalisation strategies,” says Orthofan CEO Fabio Fantozzi. “However, this is not an achievement, but only the starting point to be able to monitor internal processes and constantly improve performance, in order to offer innovative and ever higher quality services. This certification is in fact necessary for the registration and sale of the above-mentioned medical devices in the most important European markets and in territories with interesting potential such as Russia, Saudi Arabia, Yemen, the Arab Emirates and Lebanon, which Orthofan does not currently cover.


“The ISO 13485 certificate is another important step in our continuous improvement process. Quality, a distinctive element of made-in-Italy production, and its certification, are competitive advantages recognised by our customers, our staff and all our partners,’ Stefano Vallorani and Nico Baldassarre, respectively Quality Assurance and Business Consultant at Orthofan, comment with satisfaction.


The application of the standard ensures that all company processes are carried out according to specific standards and that all phases of activities are controlled and verifiable, with continuous monitoring and improvement of the service, to ensure greater reliability and efficiency internally and towards customers.


“This coveted recognition, achieved at the end of hard compliance work, represents for our own-brand medical devices a further interesting opportunity for commercial development in dependence of the continuing demand from those new markets, hitherto precluded by regulatory constraints,” concludes Fabio Fantozzi, CEO Orthofan Srl. Orthofan Srl manufactures all orthognathic devices in the industry: removable, fixed, functional, gnathological, pre-prosthetic devices and state-of-the-art digital technology including 3D scanners, CAD software and 3D printing machines for the production of resin models for sports mouthguards and other customised medical devices including transparent sequential aligners, manufactured by sophisticated 3D set-ups and validated by a clinician.