At Asphalion we can facilitate your product’s MedTech journey in the UK and US environments.
Our expertise and high knowledge and understanding of both US and UK regulations can help you establish the best regulatory strategies in these two markets.
Have a look at everything we can help you with!
For further information, send us an email at: [email protected]
You can also schedule a free 30-minutes meeting with our experts HERE.
Have a look at our MedTech UK & US Solutions
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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.
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Schedule here a free 30-minutes meeting with one of our consultants and tell us about your project, challenges or doubts.
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