by Waltteri Sorvisto | Sep 11, 2025 | FDA, Medical Device Services
For many medical device companies, the United States is not only one of the largest healthcare markets in the world—it’s also a gateway to global opportunities. FDA clearance or approval is widely recognized as a gold standard in medical device regulation, and...
by Waltteri Sorvisto | Sep 4, 2025 | FDA, Medical Device Services
When bringing a medical device to market, one of the most important strategic choices manufacturers face is deciding whether to pursue approval in the United States under the FDA or in the European Union under the EU-MDR. Both frameworks are globally respected, but...
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...
