Medical devices

S.I.I.T. manages the entire production phase of medical devices: from design to collection of technical, clinical and toxicological data up to labelling, following the procedures required by the Certifying Body and in full compliance with the standards set by current regulations.

S.I.I.T. plays a crucial role in ensuring that medical devices are safe, effective, and meet the necessary standards before they reach the end-users guaranteeing a high level of quality and safety for the medical devices they manage.

S.I.I.T. developes and produces a wide range of medical devices in formulations which cover various therapeutic areas. The Facility authorized to develop & manufacture under ISO 13485.

Medical device’ means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:

— diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease,

— diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability,

— investigation, replacement or modification of the anatomy or of a physiological or pathological process or state,

— providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations,

and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means.

Up to now more than 50 medical device has been registered by S.I.I.T.’s regulatory staff.