Gogoa se registra en EUDAMED
- Gogoa Mobility Robots
- Feb 8, 2023
- 1 min read
Updated: Jul 5, 2023
Gogoa Mobility Robots ya se encuentra registrado como fabricante de productos sanitarios en la base de datos EUDAMED
El 1 de diciembre se publicó el primer módulo (“Actor Registration Module”) de la base de datos EUDAMED de la Comisión Europea, un elemento crítico del Reglamento 745/2017 (MDR) y el Reglamento 746/2017 (IVDR) de la Unión Europea. Gogoa Mobility Robots ya ha realizado dicho registro como fabricante de productos sanitarios y ha recibido la aprobación por parte de la Agencia Española de Medicamentos y Productos Sanitarios para su publicación, asignando el SRN correspondiente.
EUDAMED proporcionará una imagen viva del ciclo de vida de los productos sanitarios disponibles en la Unión Europea y se aumentará la transparencia y coordinación entre los estados miembros. Estará compuesto por 6 módulos y se espera que los cinco módulos restantes se implementen antes de la fecha de aplicación de la base de datos, 22 de mayo de 2022. Los módulos restantes abordarán las siguientes cuestiones: Unique Device Identification (UDI), registro de dispositivo y certificados correspondientes, listado de organismos notificados, investigaciones clínicas y estudios y vigilancia del mercado.
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Congratulations to Gogoa Mobility Robots for successfully registering in EUDAMED! This achievement highlights their commitment to EU compliance and patient safety. It’s inspiring to see innovative companies advancing medical technology while meeting strict regulatory standards, promoting transparency and trust in the healthcare industry. Just like students seek reliable CIPD Assignment Help UK, businesses also benefit from expert guidance.
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