The Product-Monitor for manufacturers of medical devices
The new EU Medical Device Regulation (MDR) obliges manufacturers to monitor medical devices after they have been placed on the market (PMS / Post-Market Surveillance).
This includes a systematic collection and analysis of real-world data (PMCF / Post-Market-Clinical-Followup).
The following objectives are to be achieved:
Identify product defects or systematic application errors promptly and counteract them proactively
Reduce complaints or evaluate them on a sound basis
Continuously optimise safety, performance and usability
identify off-label uses
detect statistically significant increases in the frequency or severity of adverse events (monitoring trends)
The Product Monitor supports medical device manufacturers in meeting these complex requirements and includes:
We enable a secure and structured data acquisition with the EyeQ App. This includes the individual design of data acquisition forms, the provision of hardware and the management of data acquisition in medical practices.
By using plausibility checks, input rules and the possibility to transfer case data between medical institutions, we can guarantee a holistic data acquisition with high data evidence (real-world evidence).
We provide the prepared data in online and offline reports. Our reports include innovative score analyses, dashboards and various frequency analyses.
The online product report (via Microsoft PowerBI) allows individual data analysis and includes various filter functions.
The Offline Product-Report provides a clear summary of the monthly results.
With the real-time alarm function, we enable rapid intervention in case of irregularities.
The system pro-actively alarms about the occurrence of serious complications, the exceeding of defined threshold values or significant quality fluctuations.
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