NEWS | New Notified Body designated for IVDR

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