A clinical investigation can be well managed, completed according to plan and still leave the manufacturer with an uncomfortable question: Did we actually generate the evidence we need? For medical device companies, the purpose of a clinical investigation is not...
Clinical investigations rarely place the same demands on every medical device company. Some organisations have experienced internal clinical teams and need support only with a specific phase, such as monitoring or authority submissions. Others may need broader...
Before a clinical investigation begins, one of the most important questions must be clearly answered: What exactly is the manufacturer trying to prove? Clinical investigations do not exist in isolation. They must be directly aligned with the device’s intended use, its...
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 off...
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 meets...
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 processes...
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...
