Quality assurance forum

Approval of clinical Medical Devices

Published on 03 15, 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 attachment X of the MDD 93/42/EC Spencer Italia S.r.l. has carried out the  clinical evaluation of all Medical Devices  which are on the market in her name. The reason for this evaluation is to bring to light, starting from the literature, the history and clinical tests, the reliability and the efficiency of the device being examined. The information gathered for the evaluation of the cost-benefit aspects is based on similar or equivalent items in terms of both technology and construction methods.

The information included in the documents regards the typical operating context and functional use of the Medical Device.

Should any of the information collected be ambiguous or not sufficiently clear, the evaluation of a product equivalent is performed and more precisely, the evaluation of an equivalent takes into consideration  the following aspects:

  • CLINICAL: conditions and destination of use, parts of the body involved, characteristics of the population where the device would be used;
  • TECHNICAL: similar conditions of use, chemical and physical specifications of similar device, similar operational principles, design and project
  • BIOLOGICAL: correspondence between materials that will come into contact with body tissues or liquids.

The functional and performance characteristics of Spencer Medical Devices  are studied to make them easy  to use and to handle. This, together with the enormous attention paid to the high quality standards during the planning stage, the choice of materials and of the operations, enable us to offer a product which respects the requirements of emergency scenarios and can safely placed onto the open market.