From Idea to Approval: What Every Medical Device Needs — Expert Interview #1

As part of our ongoing exploration of the scientific, technical, and regulatory foundations behind the Nabiheal project, we are excited to present the first in a series of four expert interviews. This interview was conducted thanks to the support and collaboration of the University of Maribor (UM).

In this edition, we speak with Sergio Veiga from Asphalion, our regulatory and ethics partner. Sergio offers a clear and insightful overview of the essential steps required to bring a medical device to the European market under the Medical Device Regulation (MDR).

He explains the critical importance of proper device classification, meeting safety and performance requirements, preparing comprehensive technical documentation, and collaborating effectively with a Notified Body. Most importantly, he highlights why involving regulatory and quality experts from the very beginning of product development can shape the success of the entire project.

 Let’s dive into this insightful interview with one of our key experts!