Home Medical Devices Clinical Affairs Claims
In addition to the determination of the intended purpose, the definition of claims plays an essential role in determining the clinical strategy for your medical device. How can the claims be substantiated, especially the clinical ones? Is there sufficient scientific and clinical evidence or are additional measures needed to prove evidence? What is the true benefit of your (future) device? Answering these questions is essential for regulatory compliance and approval in all stages of the lifecycle of your device.
- LITERO supports you in defining and validating the claims of your medical device by evaluating the available scientific and clinical evidence
- We develop your clinical strategy and identify scientific publications to demonstrate the association between your device function and the therapeutic or diagnostic benefit
- We assess the methodological quality and scientific validity of all sources from which scientific conclusions are to be drawn
- We conduct a gap analysis and support you in defining all further steps in case of gaps in the clinical evidence of your device