Have a look at this infographic we have prepared showcasing the interference between Clinical Trials Regulation (EU) 536/2014 and on In vitro diagnostic medical devices Regulation (EU) 2017/746 (IVDR): INTERFERENCE BETWEEN CTR and IVDR
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Navigating the regulatory pathways for medical device approval in the United States can be complex. Two of the key components in this journey include the Pre-Submission process and 510(k) clearance, both of which engage with the Food and Drug Administration (FDA) to ensure that new or modified devices meet safety standards while supporting innovation and technological progress.
Today, Francisco Rodríguez participated in an engaging roundtable discussion, “Breaking Barriers: Navigating HealthTech Market Access in a Dynamic Landscape,” co-organised by Biocat, BioRegion of Catalonia.
Asphalion te invita a participar en una jornada única, diseñada para profesionales del sector sanitario y farmacéutico que deseen profundizar en los principales desafíos y
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As a company committed to sustainability, we follow the UN’s 2030 Agenda and its Sustainable Development Goals.
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As a company committed to sustainability, we follow the UN’s 2030 Agenda and its Sustainable Development Goals.
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