Proper protocol design and analysis will improve the quality of the medical device clinical study submission for approval, contribute to cost-efficiency, and help accelerate the introduction of your product to market.
Our team can assess PMCF study requirements for your device. The MDR places greater emphasis on PMCF and introduces changes to the procedure for demonstrating PMCF compliance. In fact, data accepted under the current MDD may no longer be sufficient under the new MDR.
ECLEVAR DIGITAL can efficiently conduct PMCF studies and clinical data analysis.
Here’s how we can help:
• Assist with creating your PMCF plan and necessary documentation
• Clearly define the objective of your postmarket clinical follow-up study
• Negotiate with your notified body upfront to ensure they find the proposed study plan acceptable
•Design the study and create a protocol
• Execute the PMCF study in many European countries
• Analyze data from your study to determine acceptability under the MDR
To make our approach possible and effective, we create our RWE database based on the global patient journey including the different points of care from the diagnostic to the follow-up:
• Aggregating retrospective data (hospitals, nurses, GP, care givers, etc.)