New entry at Asphalion’s MedTech Blog | Understanding the regulatory bodies’ standpoint concerning the submission of regulatory files

We are thrilled to announce that the Asphalion team will be attending RAPS Euro Convergence 2025, taking place in Brussels!  Join us in booth #23

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.