Introduction to the COMBINE Programme The European Union has taken a significant step towards streamlining combined studies involving medicinal products,... read more
MDCG 2020-16 is a key document outlining the classification rules for in vitro diagnostic medical devices (IVDs) under the EU... read more
The Medical Device Coordination Group (MDCG) recently released guidance MDCG 2024-10, focusing on the clinical evaluation of orphan medical devices.... read more
The Investigator´s Brochure (IB) is a critical document in the realm of clinical research for medical devices. As mandated by... read more
ISO 20916: Introduction ISO 20916, “Clinical performance studies using specimens from human subjects – Good study practice” was first published... read more
Introduction In the highly regulated and competitive world of medical device development, the choice of a Clinical Research Organization (CRO)... read more
The Medical Device Regulation (MDR) 2017/745 has transformed the EU’s regulatory landscape for medical devices. It aims to boost patient... read more
Selecting an ISO 14155-compliant MedTech CRO under EU MDR ensures enhanced data reliability and patient safety. This compliance is key... read more
The EU Medical Device Regulation (MDR) has established a rigorous regulatory framework for the entry of investigational devices into the... read more
The In Vitro Diagnostic Medical Devices Regulation (IVDR) has introduced a stringent regulatory framework for the importation of In Vitro... read more
In the field of medical device regulation, the European Union’s In Vitro Diagnostic Medical Devices Regulation (IVDR) exemplifies the EU’s... 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
FDA’s new LDT regulation underscores the vital role of IVD CROs in compliance and safety. Phased over four years without... 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
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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