by Waltteri Sorvisto | Sep 3, 2026 | FDA, Medical Device Services, Technical Documentation
A medical device company planning to enter both the European and US markets does not necessarily need to treat the two regulatory pathways as completely separate projects. The submissions themselves are different, and the regulatory logic behind them is different. But...
by Waltteri Sorvisto | Jun 11, 2026 | FDA, Quality Management
For European medical device companies, entering the US market often requires adjusting to a different regulatory system. The FDA pathway has its own terminology, submission routes, inspection expectations, and post-market requirements. Even companies with mature EU...
by Waltteri Sorvisto | Mar 5, 2026 | FDA, Medical Device Services
For many European medical device and IVD manufacturers, regulatory interaction often happens at defined checkpoints. Under the EU MDR or IVDR, communication with notified bodies typically becomes most intensive once documentation is ready for review and conformity...
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,...
