Examinando por Materia "SUMINISTROS MÉDICOS"
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Ítem Análisis del impacto de la variación de la TRM en el costo de compra de dispositivos médicos de uso masivo, importados por diferentes empresas del sector salud para la IPS Virrey Solís en los años 2019 al 2022(Universidad EAFIT, 2023) Henao Grisales, Lina Marcela; Castro Hoyos, Sebastián; Gómez Salazar, Elkin ArcesioÍtem Guía de integración de la gestión de la calidad y la normativa legal colombiana para el diseño, desarrollo, fabricación, comercialización y exportación de dispositivos médicos clase I y IIa(Universidad EAFIT, 2023) Mantilla Caballero, Fredy Alonso; Giraldo Hernández, Gina María; Velásquez Cuartas, Jhon OrlandoA guide is presented for the integration of the quality management system of class I and IIA medical devices and the regulatory aspects in the Colombian framework, applicable in the design, development, manufacture, commercialization and export of Medical Devices. An investigation of the current normogram was carried out in the databases of Invima and the Ministry of Health and Social Protection, the NTC-ISO 13485:2016 standard was reviewed; Inquiries were made in articles in electronic databases, technical consultations with Invima regarding the interpretation of the regulation and experts in the sector. This study and the application guide made it possible to identify methodologies and practical recommendations for the sector, by granting recommendations based on comments from experts in it, also leading to strengthening knowledge as a guide to medical device manufacturing companies in Colombia.