Since the Medical Device Regulation (MDR) came into force, there has been an increased focus on Post-Market Surveillance (PMS) of medical devices. Notified Bodies are now more thorough than ever and scrutinize the PMS process – from planning to the final report – as part of their desk reviews or audits.

Software in medical devices comes in various forms: embedded in the device, as an accessory or as stand-alone Software as Medical Device (SaMD). A broad spectrum of data sources must therefore be taken into account in PMS., and not just because of possible interfaces to hardware.
These include Software of Unknown Origin (SOUP) and standard software (Off-The-Shelf, OTS), with their potential anomalies.

For PMS teams, managing and analyzing the large volume and variety of data generated by a medical device requires a great deal of effort.
This is because all data and information sources that could provide indications (signals) on the safety and performance of the medical device must be identified and monitored.
These include complaints, incidents, undesirable side effects, specialist literature on competitor products and their recalls as well as feedback from the market.

The PMS team uses a PMS plan for the collection and processing of information as the basis for final reports that are included in the technical documentation. Parallel risk management and clinical evaluation processes use the PMS Report or the Periodic Safety Update Reports (PSUR) in their benefit-risk analysis. This ensures the safety of the product and its clinical performance throughout its life cycle.

PMS also provides valuable insights for the product:

Through careful analysis and categorization, the ratings can be used to identify input for trend reporting for common and recurring problems that might otherwise go unnoticed.

Error logs generated by an app management tool also provide insights into technical problems encountered by users. They should be reviewed regularly to identify patterns and determine the severity and causes of issues. Finally, if the development team proposes changes, an impact analysis as part of the change process must ensure that no new problems arise due to dependencies.

PMS of medical devices also includes the implementation of surveys that make it possible to obtain structured feedback from users. By selecting and processing these data sources, PMS can provide a comprehensive understanding of the user experience – a sound, data-driven decision-making basis for manufacturers to optimize their product.

The most important motivation for establishing a well-designed PMS system for medical devices is, of course, compliance with the MDR regulations. But there are other advantages too. A state-of-the-art and well-designed analysis process optimizes the use of human resources and improves the quality of data analysis.

Software tools provide support for the automation and rationalization of data collection and processing tasks. This reduces the workload and avoids errors in recurring tasks. It also frees up time that employees can use to critically review the available information and prepare meaningful conclusions for reporting.

Cybersecurity is of paramount importance for ensuring product availability, data integrity and the protection of Personally Identifiable Information (PII) in medicine.
Here too, software tools for evaluating publicized software vulnerabilities can be integrated into the PMS data evaluation process.

Our customized PMS service meets the strict requirements of the MDR while providing an accurate representation of the safety and performance of your medical device. Do you want to establish your own PMS system for planning, data collection and analysis in your company? Or do you need a reliable partner to create the PMS plan and all the reports associated with the safety class for Post-Market Surveillance? We will ensure that you continuously comply with all MDR requirements and thus support safe and efficient patient care.