CENTRO DI DOCUMENTAZIONE SUI DISPOSITIVI MEDICI

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For eighteen years DDC Consulting have been working in Italy and abroad offering consulting services in various sectors. -Person Responsible for the Compliance of the Regulations, mandatory figure for all manufacturers, agents, and in specific cases for distributors and importers, introduced by the new Medical Devices Regulation; -Temporary Managing; -Legal advice, CAE (Court Appointed Expert) and EW (Expert Witness); -Auditor for Notification Bodies; -Trademarks and Patents; -Quality Management Systems, implementation and maintenance; -CE Marking Medical Devices, realization of technical documentation and assistance; -Internal Audits; -Audits by suppliers; -Training: Quality, Medical Devices, Specific Products; -Technical Advertising documentation, realization and modification; -Designing new products, modification existing products; -Production processes, implementation and modification; -Marketing. In the meantime we have also developed Sports sect...

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Updated to / Aggiornamento al  02.03.2018 Weekly overview report of RAPEX notifications LINK> REPORT RAPEX EN RAPEX is established as the EU rapid alert system that facilitates the rapid exchange of information between Member States and the Commission on measures taken to prevent or restrict the marketing or use of products posing a serious risk to the health and safety of consumers with the exception of food, pharmaceutical and medical devices, which are covered by other mechanisms. As of 2010, the system also facilitates the rapid exchange of information on products subject to EU harmonisation regulation and posing a serious risk to the health and safety of professional users as well as on those posing a serious risk to other public interests protected via the relevant EU legislation (e.g. environment and security). Both measures ordered by national authorities and measures taken 'voluntarily' by producers and distributors are reported by RAPEX. Every ...

Nell’impiego della cannula aspirasaliva monouso si corrono due rischi operativi a cose normali. 1-rischio di contenzioso là dove si verifica un’accidentale aspirazione dei tessuti molli del paziente o là dove la fuoriuscita del filo in metallo ferisce il paziente o l’assistente; 2-rischio di contaminazione del campo operatorio. La cannula aspirasaliva è infatti venduta NON sterile e confezionata in comunissimi sacchetti di plastica spesso forati per evitare la formazione interna di condensa. La cannula non è sterilizzabile in autoclave. Ma se questo rischio non bastava adesso si aggiunge un rischio “Multa” non da poco. In un interessante articolo di Norberto Maccagno su Odontoiatria33 “ Il bullone e l'aspirasaliva, la fattura che descrive più o meno, il dove si trova il credito ed il sito rinnovato ” si disquisisce sulla pratica discutibile che l’Agenzia delle Entrate utilizza per contestare il reddito dichiarato dai dentisti. Pratica ribadita in cassazione in fa...