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 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. It includes 3 Modules:

Secure and pseudonymised capture of real-world data


  • Provision of hardware and management of data acquisition in medical practices

  • Individual design of data entry forms

  • Training and ongoing support for medical practices to ensure high data quality

  • Constant monitoring of incoming data


Provision of the prepared data in reports


  • Online access to reports with various analyses, dashboards, filter functions and customization options

  • Initial presentation and application training

  • Continuous further development of the analyses


Proactive alerting of any irregularities


  • Definition of individual alarm triggers such as serious complications or threshold values

  • Automatic sending of alarm emails in real-time

  • Use of artificial intelligence to detect irregularities in case data