Lead Medical Writer
Pia is a Lead Medical Writer, producing high-quality regulatory documents and scientific communications for pharmaceutical and biotech clients.
11 articles
Descubre lo que se requiere para obtener y mantener la aprobación de comercialización para el Software de Dispositivos Médicos en la UE.
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With the introduction of the Medical Device Regulation (MDR), the requirements for placing medical devices on the market have significantly increased. Additional manufacturers’ obligations concerning post-market surveillance (PMS), including post-market clinical follow-up (PMCF), have gained importance.
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Aunque los fabricantes dispondrán de más tiempo para preparar sus expedientes técnicos para la transición al MDR, es aconsejable no retrasar la implementación hasta el último minuto. Aprende a planificar el cumplimiento de MDR para tu dispositivo médico aquí.
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Explora el campo de la redacción médica y los diferentes tipos de proyectos de redacción médica en Sanidad. En QbD Clinical estaremos encantados de ayudarte.
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En los últimos años, QbD group ha acumulado una amplia experiencia en guiar a los fabricantes hacia **la aprobación CE para sus productos sanitarios**, que ahora incluye el cumplimiento de la MDR.
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Conoce los distintos pasos y documentos necesarios para realizar la revisión bibliográfica del estado del arte para la evaluación clínica de tu producto sanitario.Conoce los distintos pasos y documentos necesarios para realizar la revisión bibliográfica del estado del arte para la evaluación clín...
Read moreDiscover what is required to obtain and maintain marketing approval for Software Medical Devices in the EU.
Read moreOver the past years, the QbD Group has amassed extensive experience in guiding manufacturers towards CE approval for their medical devices, now including compliance under MDR.
Read moreLearn the various steps and required documents for conducting the State of the Art literature review for the clinical evaluation of your medical device.
Read moreAlthough manufacturers will have more time to prepare their technical files for the MDR transition, it is wise not to delay implementation until the last minute. Learn how to plan MDR compliance for your medical device here.
Read moreExplore the field of medical writing and the different types of medical writing projects in Healthcare. QbD Clinical is happy to help!
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