
MDR Article 62.2: The Role of Clinical Investigation Legal Representative
MEDTECH news November 25, 2023In the intricate world of medical device regulation, the European Union Medical Device Regulation (EU MDR) stands out as a... read more
In the intricate world of medical device regulation, the European Union Medical Device Regulation (EU MDR) stands out as a... read more
The world of medical device regulation is constantly evolving, with regulatory bodies introducing new guidances to keep up with the... read more
The Food and Drug Administration (FDA) recently released a groundbreaking proposed rule on September 29, 2023, aiming to transform its... read more
The Medical Device Coordination Group (MDCG) plays a key role in setting the rules for medical devices in the European... read more
Introduction In the rapidly evolving world of in vitro diagnostics (IVD), manufacturers are increasingly understanding the need for rigorous clinical... read more
WHO publishes specifications for monkeypox tests The World Health Organization (WHO) has recently unveiled two pivotal Target Product Profiles (TPPs)... read more
The evolving landscape of Companion Diagnostics (CDx) introduces complexities in regulatory and certification processes. Engaging in IVDR Companion Diagnostic Consulting... read more
State of play of IVDR Transition: In the realm of in vitro diagnostics (IVD), a seismic shift is underway as... read more
At MDx CRO, our specialized IVD regulatory services cater not only to in vitro diagnostic medical device manufacturers, companion diagnostics... read more
The field of companion diagnostics IVD (CDx) represents a confluence of technological innovation, regulatory compliance, and patient care. As personalized... read more
New position statement published by the IVD expert panel on influenza viruses MDx CRO, an IVD consultancy and CRO company,... read more
Striking a balance between expertise and cost-efficiency in IVD consultancy can be a tricky task, especially within the European Union’s... read more
At the crossroads of healthcare and technology, Clinical Molecular Genetics (CMG) emerges as a keystone, bridging molecular biology and genetics... read more
The recent amendment of the Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) through Regulation (EU)... read more
EU Commission evaluates EURLs The European Commission is making significant progress in evaluating applications for EU reference laboratories (EURLs) to... read more
In this article, we will delve into the intricacies of developing a robust Clinical Evaluation Plan using expert regulatory terminology,... read more
The field of personalized medicine is experiencing notable progress as BSI and TÜV SÜD, two of the largest Notified Bodies... read more
How are medical devices without an intended medical purpose regulated under the MDR Annex XVI? Continue reading to learn more.
Are you ready for the new regulation on In Vitro Diagnostic medical devices in Spain? Learn everything you need to... read more
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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