Tecnovigilancia; sistema de vigilancia de dispositivos médicos

Abstract

Technovigilancy is a new action in Mexico, it was born in USA in 1976, to grantee the efficiency and safety of medical devices. It can be a code, document that contains mandatory requirements; it uses the word shall, is generally adopted into law by authoroty that has jurisdiction, and Standard, document that contain mandatory requierements, but compliance tends to be voluntary; In Medical Equipment the clasification of the reports is divided in 3 diferents class I, II and III in which higher number indicate higher risk; This notifications are given to the industry in order to prevent and repair the mane problem of the surce. © Springer-Verlag Berlin Heidelberg 2007.