{"id":27607,"date":"2023-04-21T15:38:56","date_gmt":"2023-04-21T13:38:56","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=27607"},"modified":"2023-04-21T15:39:33","modified_gmt":"2023-04-21T13:39:33","slug":"miriam-cangi-project-manager-thema","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/es\/2023\/04\/21\/miriam-cangi-project-manager-thema\/","title":{"rendered":"Miriam Cangi &#8211; Project Manager de Thema"},"content":{"rendered":"<h2><span class=\"ui-provider gz b c d e f g h i j k l m n o p q r s t u v w x y z ab ac ae af ag ah ai aj ak\" dir=\"ltr\">Miriam Cangi, <strong>Project Manager<\/strong> de Thema, respondi\u00f3 a algunas preguntas sobre su trabajo y su funci\u00f3n, brind\u00e1ndonos valiosos consejos. Conozc\u00e1mosla juntos&#8230;<\/span><\/h2>\n<h3><strong>\u00bfCu\u00e1l es tu papel en Thema?<\/strong><\/h3>\n<p>Mi funci\u00f3n en Thema es la de Gestor de proyectos. Concretamente, me encargo de la gesti\u00f3n operativa de un proyecto, empezando por la definici\u00f3n de la estrategia de ejecuci\u00f3n de las actividades hasta la entrega del resultado final al cliente.<\/p>\n<h3><strong>\u00bfQu\u00e9 es lo que m\u00e1s te gusta de tu trabajo?<\/strong><\/h3>\n<p>Es un trabajo variado, nunca mon\u00f3tono. Cada actividad es diferente de la anterior. Porque las reglas son las mismas para todos, pero cada caso es diferente. Me gusta sumergirme en la realidad de cada cliente y ayudarle a superar todos los obst\u00e1culos. Cada d\u00eda est\u00e1 lleno de nuevos retos y esto es muy estimulante para m\u00ed.<\/p>\n<h3><strong>\u00bfQu\u00e9 estudios y experiencias le han tra\u00eddo hasta aqu\u00ed?<\/strong><\/h3>\n<p>Obtuve mi M\u00e1ster en Ingenier\u00eda Biom\u00e9dica en la Universidad Polit\u00e9cnica de Tur\u00edn. Adquir\u00ed mi experiencia profesional en el \u00e1mbito regulatorio en primer lugar durante el desarrollo de mi tesis de M\u00e1ster, a trav\u00e9s de la redacci\u00f3n de la Documentaci\u00f3n T\u00e9cnica de un Dispositivo M\u00e9dico innovador para ventilaci\u00f3n no invasiva seg\u00fan el Reglamento MDR (UE) 2017\/745. Posteriormente, realic\u00e9 actividades de consultor\u00eda en el \u00e1mbito estrat\u00e9gico-regulatorio apoyando a mis Clientes en la elaboraci\u00f3n de expedientes t\u00e9cnicos para el marcado CE de Productos Sanitarios y en la adaptaci\u00f3n de los procesos del SGC al MDR.<\/p>\n<h3><strong>\u00bfQu\u00e9 caracter\u00edsticas te han hecho una buena consultora?<\/strong><\/h3>\n<p>Una predisposici\u00f3n a escuchar activamente y descubrir las verdaderas necesidades de mis clientes, centr\u00e1ndome especialmente en lo que no se dice o expresa expl\u00edcitamente.<\/p>\n<p>Pero tambi\u00e9n mi orientaci\u00f3n al crecimiento profesional, mi disposici\u00f3n a aprender cosas nuevas y la necesidad de mejorar constantemente lo que hago.<\/p>\n<h3><strong>\u00bfCu\u00e1les son las principales necesidades de los clientes?<\/strong><\/h3>\n<p>En estas fechas recibo muchas solicitudes relativas a la pr\u00f3rroga del MDR, publicado en el Diario Oficial el 20 de marzo de 2023. Los fabricantes me preguntan si les es aplicable la pr\u00f3rroga del periodo transitorio prevista en el art\u00edculo 120 del MDR (UE) 2017\/745. Aunque muchos pueden beneficiarse de la pr\u00f3rroga, mi consejo es que no esperen e inicien ya el proceso de adaptaci\u00f3n, dada la complejidad de las actividades y pasos que conlleva el proceso de certificaci\u00f3n CE. Adem\u00e1s, a menudo recibo solicitudes de apoyo de fabricantes europeos que quieren entrar en mercados no pertenecientes a la UE, como Estados Unidos.<\/p>\n<h3><strong>\u00bfQu\u00e9 tipo de no conformidad encuentra con m\u00e1s frecuencia entre sus clientes?<\/strong><\/h3>\n<p>A menudo me encuentro con la ausencia de un Acuerdo T\u00e9cnico de Calidad (ATC) entre Operadores Econ\u00f3micos en el contexto del Reglamento MDR (UE) 2017\/745. Este acuerdo es esencial para establecer las responsabilidades entre las diferentes partes en relaci\u00f3n con las actividades que podr\u00edan tener un impacto directo en la calidad, seguridad y eficacia de los Productos Sanitarios una vez comercializados.\u00a0 Una No Conformidad recurrente es la ausencia de la documentaci\u00f3n necesaria para describir el dise\u00f1o y el proceso de fabricaci\u00f3n de un Producto Sanitario, tal y como exige el Anexo II del MDR.<\/p>\n<h3><strong>El mejor consejo para tus clientes<\/strong><\/h3>\n<p>Est\u00e9 abierto al cambio, s\u00f3lo as\u00ed podr\u00e1 mantenerse al d\u00eda en el siempre variable mundo normativo del sector m\u00e9dico. Adem\u00e1s, como ya he dicho, no espere para solicitar consultor\u00eda, ya que los tiempos y los procesos en Calidad y Reglamentaci\u00f3n son especialmente complejos.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Miriam Cangi, Project Manager de Thema, respondi\u00f3 a algunas preguntas sobre su trabajo y su funci\u00f3n, brind\u00e1ndonos valiosos consejos. 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