Àrea Clients / Col·laboradors

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Els dispositius mèdics o productes sanitaris són tots aquells instruments, equips, implants, materials, etc. destinats al diagnòstic, prevenció i tractament de malalties en éssers humans. També poden tenir altres funcions, com ara el control de la gestació, etc. Aquests productes es regulen amb una normativa molt estricta, que pot variar en funció del país on es comercialitzi el producte. Els dispositius mèdics es classifiquen en els grups següents:

Com més gran és el grau de risc i com més invasiu és el dispositiu, més crítica és l’adequació de la traducció. No hi ha marge d’error. Tots els textos relacionats amb aquests dispositius, com ara IFUs (instruccions d’ús), manuals d’usuari, etiquetatge, software, catàlegs o fulletons, han de ser fidels a l’original, exactes i precisos. Per això, els nostres lingüistes són especialistes tècnics amb solvència demostrada i, a més, el procés de revisió exhaustiu que exigeix la norma ISO 17100 garanteix una traducció sense errors, incoherències i inexactituds.

Entre els nostres clients de dispositius mèdics més importants es troben fabricants de: equips de cirurgia ocular, d’ecografia, desfibril·ladors externs, implants per a traumatologia, pròtesis per a cirurgia ortopèdica, implants dentals, aparells per a cirurgia estètica, equips de diagnòstic per la imatge, sutures i malles quirúrgiques, equips electromèdics, electroestimuladors per a fisioteràpia, productes per a la salut bucal, sistemes de diagnòstic in vitro, dispositius intrauterins, equips de monitorització no invasiva…
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• IFUs (Instruccions d’ús)
• Packaging
• Etiquetatge
• Fulletons
• Manuals de funcionament

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• Guies ràpides d’ús
• Estudis d’estabilitat
• Dossiers tècnics
• Catàlegs de productes
• Fulletons i contingut web

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• Consentiments informats per a assajos
• Registres de protocols
d’investigació clínica
• Localització de software de
dispositius mèdics
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MDR is the new set of regulations governing the production and distribution of medical products in Europe. In this article, we tell you all about this new regulation.