In recent years, there has been a dramatic increase in the use of digital health tools health in order to improve service quality, system effectiveness, and facility administration. The COVID-19 epidemic hastened this pattern. eHealth, often known as digital health,... read more
Because the electronic system referenced to in Article 73 (Eudamed) will not be ready and completely functioning on the MDR’s effective date, this guideline covers the processes for safety reporting in clinical research in the absence of Eudamed. MDCG 2020-10... read more
Assisting with the EU Medical Devices Regulation Europe faces imminent shortages of medical equipment needed by hospitals and clinicians to treat patients. This dangerous disease affects both new and old devices. The EU institutions must take urgent and decisive action.... read more
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... read more
To create a consistent approach to the requirements of technical documentation submissions from manufacturers, members of Team NB reviewed the best practice guidance documents that each Team NB notified body member had submitted. They then prepared this best practice guidance... read more
Due to the usage of shared software components, #cybersecurityvulnerabilities may affect a wide variety of apparently secure unconnected products from different manufacturers. Compounding the issue is the limited traceability of many common components in electronical #medicaldevices.
The main purpose of this new guidance t is to create uniform expectations and understanding for Machine Learning-enabled Medical Devices (MLMD), improve patient safety, inspire innovation, and encourage access to breakthroughs in healthcare technology. Artificial Intelligence (#ai ) is an... read more
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.
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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