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...
by Waltteri Sorvisto | Jun 12, 2025 | Medical Device Services
This spring, our consultants at MDS have been deeply involved in several intensive regulatory milestones. We supported clients through multiple Stage 1 and Stage 2 MDR audits, and participated in the TDA (Technical Documentation Assessment) process for various...
by Waltteri Sorvisto | Jun 5, 2025 | Medical Device Services
The shift from the In Vitro Diagnostic Directive (IVDD) to the In Vitro Diagnostic Regulation (IVDR) represents a significant overhaul in the regulatory landscape for in vitro diagnostic medical devices within the European Union. This transition aims to enhance...
