The healthcare industry is undergoing a rapid transformation spurred by the advent of advanced medical diagnostic technology. IVD software development... read more
If you are still undecided on which Notified Body (NB) to choose or you’re in the early stages of development,... read more
One of the critical steps in IVD development is the conduct of an IVDR clinical performance study to generate reliable... read more
MDx summarize the key updates to the MedTech Europe Regulatory eBook Clinical Evidence Requirements under the EU In Vitro Diagnostics... read more
IVDR LDT / IVDR in-house devices On May 26, 2022 the new Regulation (EU) 2017/746 on in vitro diagnostic medical devices... read more
Although there has been a significant growth in recent years in the understanding of the crucial role that diagnostics play... read more
Team-NB produced a Position Paper on measures for class D IVD in the absence of EU Reference Laboratories as a... read more
In a landmark announcement, Roche has revealed that its Ventana PD-L1 (SP263) Assay has received CE IVD approval, setting a... read more
The #IVDR Regulation (EU) 2017/746 establishes guidelines for European Union reference labs (EU reference #laboratories). Article 100(4) of Regulation (EU)... read more
Multiplex in vitro diagnostic (IVD) devices concurrently detect two or more targets/markers. Multiplex IVDs are sold as one device with... read more
65% of EMA and FDA drug approvals involved a biomarker between 2015 and 2019. Currently, 44 CDx are approved by the FDA, and the most relevant categories in terms of the number of approvals are NSCLC and colorectal cancer.
MED IVD HEALTHTECH S.L ha sido beneficiaria de la subvención de contratos de trabajo de la Comunidad de Madrid, cofinanciado por el Fondo Social Europeo dentro de la Ayuda a la Recuperación para la Cohesión y los Territorios de Europa (REACT-UE), a través del Programa Operativo Regional FSE, en el marco del Programa Impulso a la Contratación Estable de Jóvenes para la Recuperación Económica, gestionado por la Dirección General del Servicio Público de empleo de la Consejería de Economía, hacienda y empleo de la Comunidad de Madrid.
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