Quality assurance forum

Section archive


  • Medical Devices Maintenance | 23/09/2013

    The correct functioning, the life span and the validity of the CE marking of a medical device is subject to the prompt  and  correct maintenance programme carried out as indicated  by  the Manufacturer in the Instructions Manual and as prescribed ... Continue reading »

  • 10 G CERTIFICATION | 23/09/2013

    It’s a few years now that we have frequently been making reference to the EN 1865-1 and the EN 1789 which specifies requirements for the design, testing, performance and equipping of road ambulances used for the transport and care of ... Continue reading »


    Items introduced onto the markets of the European Community must meet the minimum safety requirements as indicated in the directive “new approach” with indications for each single item.   As Directives have not been created for every product, the European Community ... Continue reading »

  • Approval of clinical Medical Devices | 15/03/2013

    Medical Devices  manufactured by Spencer Italia S.r.l. are made in full respect of the essential requirements of the  Medical Devices Directive 93/42/EC (and updates)  for the product’s technical requirements and are manufactured following the Good Manufacturing Practice. Ad indicated in the ... Continua a leggere »