NAMSA, a world leading MedTech Contract Research Organization (CRO) offering global end-to-end development services, announced today its intent to acquire ÅKRN Scientific Consulting, a prominent Euro...
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Artificial intelligence (AI) is constantly bringing improvements to the field of medical devices, with AI technology being embedded in software used as a medical device or being a medical device by it...
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La demanda de productos sanitarios se encuentra en constante aumento, un nicho de oportunidades donde escasean profesionales y talento para satisfacer las necesidades del sector tecnológico-sanitario...
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When considering obtaining an ISO 13485 certificate, developing and implementing a quality management system (QMS) is not the end of the road. Indeed, medical device manufacturers must first ensure th...
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In vitro diagnostic medical devices (IVDs) are increasingly in demand as the medical technology evolves by leaps and bounds. With the application of the In Vitro Diagnostic Medical Device Regulation (...
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Safety reporting is a crucial aspect of a successful clinical investigation for medical devices. In addition to the Good Clinical Practice (GCP), stakeholders are required to comply with the Medical D...
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Performance studies for SARS-CoV-2 IVD tests have become a hot topic since the publication of the MDCG 2021-21 and the common list of COVID-19 IVD tests. These two documents have strengthened the requ...
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Everyone involved in clinical research must follow Good Clinical Practice (GCP) as specified in ICH GCP and the international ISO standard 14155:2020, the EU MDR 2017/745, the EU IVDR 2017/746, the EU...
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Clinical investigations with medical devices should be performed by health care professionals with scientific and medical qualifications and appropriate experience, preferably in the proposed research...
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This article will provide you information on MDCG 2021-21 guidance document and let you know how you can place and keep your SARS-CoV-2 IVD products on the EU market.
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AtCDF3 gene induced greater production of sugars a...
Un estudio con datos de los últimos 35 años, ind...
Un equipo de investigadores de la Universidad Juli...
En nuestro post hablamos sobre este interesante tipo de célula del...
Theriva™ Biologics has announced the presentation of preclinical da...
