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The future of diagnostics

The future of diagnostics

MEDTECH NEWS November 2, 2022

The future of diagnostics Technology driven personalised and preventative healthcare in Europe Although there has been a significant growth in recent years in the understanding of the crucial role that diagnostics play in European healthcare, diagnostics firms still confront numerous…

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Clinical Evaluation Consultation Procedure (CECP)

Clinical Evaluation Consultation Procedure (CECP)

MEDTECH NEWS October 24, 2022

This scientific opinion represents independent specialists’ opinions (MDR Article 106) on the notified body’s Clinical Evaluation Assessment Report (CEAR). Clinical Evaluation Consultation Process (CECP) is an extra aspect of conformity assessment by recognized organizations for high-risk devices (MDR Article 54…

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Making use of directive conformity evaluations to demonstrate compliance with MDR standards

MEDTECH NEWS 13 October, 2022

The members present at the general assembly expressed their overall support for the draft position document. When the paper is finished and the Commission and NBO’s feedback has been taken into consideration, a vote will be held to approve it.

Position paper on cyber security

Position paper on cyber security

MEDTECH NEWS October 13, 2022

This paper has been prepared thanks to the task force and endorsed during the general assembly meeting. It is a high level document. Improvements in patient care are more significant than new market potential for the manufacturer as a result…

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EU Reference Labs

EU Reference Labs

SOFTWARE MD/IVD NEWS August 23, 2022

The #IVDR Regulation (EU) 2017/746 establishes guidelines for European Union reference labs (EU reference #laboratories). Article 100(4) of Regulation (EU) 2017/746 specifies the requirements that must be met by EU reference labs. In order to assure adherence to these standards,…

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Multiplex #IVD devices | Assessment Common Approach

Multiplex #IVD devices | Assessment Common Approach

SOFTWARE MD/IVD NEWS August 23, 2022

Multiplex in vitro diagnostic (IVD) devices concurrently detect two or more targets/markers. Multiplex IVDs are sold as one device with their sole intended purpose. They may be intended to detect dozens of targets/markers, such as allergies or microorganisms. Due to…

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Companion Diagnostic in Precision Medicine

IVD NEWS 27 November, 2021

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.

AI and the Software as a Medical Device

SOFTWARE MD/IVD NEWS 27 November, 2021

Deep learning techniques using neural networks are used in medical devices to fulfill human capabilities in a variety of roles, such as: Disease prediction, detection, classification, and analysis.


Fondo Social Europeo dentro de la Ayuda a la Recuperación para la Cohesión y los Territorios de Europa (REACT-UE)

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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