As emerging markets open their doors to innovative healthcare technologies, Argentina is quickly becoming a top destination for MedTech expansion. In this post, we speak with Matias, Arazy Group’s Corporate Sales Manager and General Manager of the Argentine office, who shares what MedTech companies need to know about navigating regulatory access, choosing the right strategy,…
Lately, I’ve been reflecting on how often companies underestimate the complexity of global regulatory submissions. Everyone’s trying to move fast—but fast doesn’t always mean strategic. And honestly, it’s not the big, obvious challenges that cause trouble. The smaller, overlooked assumptions end up delaying launches or putting compliance at risk. After years of working with clients…
The Medical Device User Fee Amendments (MDUFA) have long been a defining feature of FDA operations, providing critical funding for regulatory processes. But do they genuinely serve the industry and public interest or introduce conflicts that could unintentionally shape the regulatory landscape? As regulatory professionals, we must ask: Are we optimizing the system for efficiency…
