by adminReaktio | Jan 30, 2025 | FDA
Weighing Your Options: FDA vs. EU-MDR Choosing between FDA and EU-MDR approval is not just a regulatory decision—it’s a strategic choice that impacts your time-to-market, costs, and long-term compliance strategy. Each pathway presents unique benefits and challenges,...
by adminReaktio | Jan 16, 2025 | FDA
Transitioning from EU-MDR to FDA: Key Considerations For European medical device manufacturers, entering the U.S. market requires an understanding of the regulatory landscape governed by the U.S. Food and Drug Administration (FDA). While both FDA and EU-MDR (EU...
by adminReaktio | Jan 2, 2025 | FDA
Navigating the Regulatory Landscape for Medical Devices Bringing a medical device to market requires compliance with regulatory frameworks that ensure safety, performance, and quality. Two of the most important regulatory systems in the industry are those governed by...
