Post-market surveillance: What happens after the product is placed on the market?

Post-Market Surveillance (PMS), i.e. the monitoring and review of approved medical devices, refers to the process after they have been placed on the market. This structured process aims to derive possible corrective measures for the product based on market behavior.

 

This is the focus of post-market surveillance

Identify risks
Determine effectiveness compared to other products
Initiate significant measures quickly
Uncover existing security problems
Update risk management

This is how we proceed for your Post-Market Surveillance

  • Analysis by MAUDE and BfArM

    Regular evaluation of reports and incidents in databases such as EUDAMED in Europe, MAUDE of the FDA in the USA, BfArM in Germany and – depending on the target market others, to identify and respond to potential safety concerns.

  • Reviews and feedback

    Continuous evaluation of reviews and feedback in app stores, forums and communities to understand user experiences and problems.

  • Feedback via support channels

    Analysis of feedback via direct support channels such as hotlinesservice engineers or e-mail to identify specific user problems.

  • Feedback within the application by End users

    Capturing feedback within the application applicationto gain insights into the user experience during actual use.

  • Feedback via the error log service

    Continuous monitoring of error logs to identify technical problems at an early stage.

  • Monitoring of market competitors

    Monitoring of similar products and their ratings for competitive analyses and improvements.

  • Monitoring cybersecurity information

    Continuous review of cybersecurity information to identify and eliminate potential security vulnerabilities.

  • Trend analyses

    By analyzing PMS data, we identify recurring patterns and trends, whether in relation to certain product functions, application areas or specific user groups.

Post-market surveillance for your medical device

This is where BAYOOMED’s expertise comes in. As part of the post-market surveillance process, all information is checked and the corresponding activities carried out – from analyses to monitoring.