Description

The regulatory landscape for medtech in the EU is increasingly complex, continuously evolving, and challenging to navigate. At the same time, in the US, medtech manufacturers can benefit from opportunities for assistance, such as the FDA’s Breakthrough Devices Designation and pre-submission meetings, which can result in faster approval. Companies face mounting challenges as they strive to keep up with the latest regulatory requirements in these major markets. The stakes are high: navigating these regulations effectively can mean the difference between swift market access and costly delays—or worse, exclusion from the market altogether. 

In this webinar, we will explore how to manage the growing regulatory demands, the crucial differences between the EU and US regulatory landscapes, and the latest updates that could impact your business. You will learn what you should consider when developing your regulatory strategies and how to prioritize target markets amidst these shifting regulations.

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