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

App

  • 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

1/2

Provision of the prepared data in reports

Report

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

  • Initial presentation and application training
     

  • Continuous further development of the analyses

1/4

Proactive alerting of any irregularities

Alarm

  • 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

1/1

EyeQProcess GmbH

Kennedyallee 111

D-60596 Frankfurt am Main

Mail: info@eyeqprocess.de

Tel.: + 49 69 509548800

Fax: +49 69 509548899