Guzmán Terán, CamiloOcampo Riveros, MonicaPeñata Duque, Hasley CarolinaRodríguez Altamiranda, Indira MilenaGonzález Villalba, José FernandoPico Herrera, Karen Esther2020-03-232020-03-232020-01-23https://repositorio.unicordoba.edu.co/handle/ucordoba/2575Introduction: the World Health Organization, calls for the purpose of expanding knowledge related to the formulation of strategies that allow the implementation of evaluation and acquisition systems, of medical devices, quality, safe and efficient. Objective: Develop a self-assessment tool that contributes to the strengthening of the Institutional Program of Tecnovigilancia in the Trauma and Fractures Clinic of the city of Monteria. Methodology: Descriptive, quantitative, cross-sectional study. Results: the evaluation of the Tecnovigilancia program of the institution under study was carried out, being in that respect that it is implemented in 87%. Conclusion: The implementation of the application allowed to consolidate in a single document all the information of the Tecnovigilancia institutional program. It also helps facilitate the analysis of compliance with the criteria according to current regulations.1. INTRODUCCIÓN ............................................................................................................................. 112. OBJETIVOS .......................................................................................................................................... 122.1. OBJETIVO GENERAL. ................................................................................................................ 122.2. OBJETIVOS ESPECÍFICOS. ..................................................................................................... 123. METODOLOGIA .................................................................................................................................. 133.1. DISEÑO METODOLÓGICO. ...................................................................................................... 133.2. POBLACION Y MUESTRA ......................................................................................................... 133.3. OBTENCIÓN DE DATOS ........................................................................................................... 133.4. UNIDAD DE ANÁLISIS ................................................................................................................ 133.5. TABULACIÓN Y ANÁLISIS DE LA INFORMACIÓN .............................................................. 143.6. CONSIDERACIONES Y ASPECTOS ÉTICOS-LEGALES .................................................... 144. MARCO REFERENCIAL .................................................................................................................... 154.1. MARCO DE ANTECEDENTES .................................................................................................. 154.2. MARCO TEORICO ....................................................................................................................... 164.2.1. Dispositivos médicos ............................................................................................................ 164.2.2. Tipos de dispositivos médicos ............................................................................................ 174.2.3. Niveles de operación del Programa Nacional de Tecnovigilancia ................................ 194.2.4. Reporte de eventos adversos. ............................................................................................ 194.2.5. Clasificación de los dispositivos médicos.......................................................................... 204.3. MARCO CONCEPTUAL.............................................................................................................. 224.4. MARCO LEGAL ............................................................................................................................ 245. RESULTADOS ..................................................................................................................................... 256. DISCUSIÓN .......................................................................................................................................... 367. CONCLUSION ..................................................................................................................................... 378. BIBLIOGRAFIA .................................................................................................................................... 38application/pdfspaCopyright Universidad de Córdoba, 2020Trabajo de grado - Pregradoinfo:eu-repo/semantics/restrictedAccessAtribución 4.0 Internacional (CC BY 4.0)TecnovigilanciaEvento adversoDispositivo médicoHerramientaTecnovigilanciaAdverse eventMedical deviceTool