HOME ABOUT US BUSINESS UNIT ASSISTANCE NEWS SOCIAL WALL CONTACTS HOW IS A GOOD MEDICAL DEVICE MADE? Safety and quality are the main characteristics required of manufacturers of consumable medical devices, in order to avoid any risk to the health of patients, both in the diagnosis and prognosis phase. But what exactly are the obligations for manufacturers? To regulate this aspect is the Directive 93/42 / EEC, which speaks clearly on the requirements required of those who produce any type of medical device: design and construction are the most critical phases and it is to them that the main indications are linked. Design The design must take into consideration materials that are not toxic, flammable and that are compatible with the human tissues with which they may come into contact. Possible infections and microbial contamination must be absolutely avoided through sterilization, cleaning and maintenance processes that the manufacturer is obliged to identify and illustrate to the buyer, so that he can use the products safely. Production Per quel che riguarda la produzione, invece, il fabbricante ha l'obbligo di assicurarsi che i rischi di lesione e di deterioramento legati all'interazione con altri dispositivi o materiali siano eliminati o minimizzati, così come i rischi legati ad eventuali guasti. L'identificazione del fabbricante dev'essere semplice, anche grazie all'etichettatura e ai codici di rintracciabilità. I consumabili DSS To comply with the Directive and guarantee quality products, our Aftermarket Business Unit offers a wide catalog of medical consumables manufactured and certified by the main brands in the medical sector, such as Rimage, Epson, Primera, Codonics and Zebra. The supply and assistance service allows not only to always have material in compliance with the regulations, but also to always have the right quantity of items, so as to avoid any lack of availability. News and events The partnership between DSS and SwitchUp continues Datamatic Sistemi e Servizi and SwitchUp together again to combine commercial and [...] DSS is the master distributor of OPEN-V Since 2017 DSS is the master distributor of OPEN-V, the only private cloud system able to support [...] DSS presents: ItalFondiario success story ItalFondiario introduced 500 new staff devices in 4 months. > All news and events THE GROUP Home page Who we are Contacts News BUSINESS UNIT Healthcare Marketing & Communication Cybercrime & Digital Forensics Unit IT Storage Aftermarket Consumables ASSISTANCE Assistance service Request for assistance Remote Support privacy policy | cookie policy Copyright © 2003 - 2016 Datamatic Sistemi & Servizi SpA VAT number 04759990155 Cookies help us deliver quality services. By using our services, you agree to our use of cookies. Cookie policyClose