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,...
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...
Completing the Clinical Investigation with Confidence A clinical investigation doesn’t end when the last patient completes the study. The final phase—reporting and post-trial activities—is just as critical as planning and execution. This phase ensures your study...
Building a Compliant Clinical Investigation from the Ground Up Before a clinical investigation can begin, several critical elements must be in place to ensure regulatory compliance, data quality, and patient safety. Under MDR (EU 2017/745) and ISO 14155, the...
The Role of Documentation in MDR-Compliant Clinical Investigations Proper documentation is the backbone of every clinical investigation. Under MDR (EU 2017/745) and ISO 14155, medical device manufacturers are required to maintain a comprehensive set of documents to...
The Importance of Clinical Investigation Planning Under MDR When preparing to bring a medical device to market under MDR (EU 2017/745), one of the most critical steps is the planning of your clinical investigation. Regulatory authorities require manufacturers to...
