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 Waltteri Sorvisto | Aug 26, 2025 | CRO
Once your clinical investigation is underway, the focus shifts from planning and preparation to execution, oversight, and data integrity. This stage is where the evidence needed for MDR (EU 2017/745) compliance—and ultimately market approval—is gathered, validated,...
by Waltteri Sorvisto | Aug 14, 2025 | CRO
While the past weeks have been quieter on our blog, our work behind the scenes has been as active as ever—supporting medical device companies in planning, managing, and executing clinical investigations. Now that the vacation season is winding down, we’re kicking off...
by Waltteri Sorvisto | Jun 26, 2025 | Medical Device Services
Throughout this spring, we’ve seen firsthand how medical device companies navigate the complex landscape of MDR—not only during audits but in the day-to-day realities of quality system maintenance. One insight has become increasingly clear: even well-established...
