Avania

Articles

The MDR: Navigating Europe’s New Standard for Medical Device Safety

October 25, 2022

Europe’s new Medical Devices Regulation (MDR) is four times longer than the previous Medical Device Directive, and it has raised the bar for clinical evaluations. It’s imperative that manufacturers proactively identify the gaps in their data and take the necessary steps to fill them — from pre-clinical through post-market. Many companies are unprepared for this task. Our guest, Dr. Kim van Noort, will walk us through some of the biggest challenges that MDR poses, and tell us how to overcome them.

Medical Device Safety: Understanding Europe's New Medical Devices Regulation

October 25, 2022

Europe’s new medical devices regulation (MDR) is four times longer than the previous medical device directive (MDD), and it has raised the bar for clinical evaluations. It’s imperative that manufacturers proactively identify the gaps in their data and take the necessary steps to fill them—from pre-clinical through post-market.

Key Considerations for Interventional Medical Devices Undergoing First-in-Human Studies

January 28, 2022

First-in-human (FIH) is a critical milestone for companies pursuing medical device development. Medical device developers often experience great pressure to shorten timelines and get to the clinic. However, it is important to keep certain aspects top of mind to have a successful FIH clinical experience.