PMS of medical devices
How Post-Market Surveillance (PMS) supports safety and performance
Since the Medical Device Regulation (MDR) came into effect, post-market surveillance (PMS) of medical devices has come into sharper focus. 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.
This poses a particular challenge for the development of medical devices. This is because such software comes in various forms: embedded in the device, as a supplementary accessory, or as standalone Software as a Medical Device (SaMD). Therefore, the PMS must account for a broad spectrum of data sources—not only because of potential connections to hardware. This includes software of unknown origin (SOUP) and off-the-shelf (OTS) software, along 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.
Assess Risks and Identify Untapped Potential with PMS
Based on a PMS plan, the PMS team compiles information to serve as the basis for final reports, which are incorporated into the technical documentation. In parallel, risk management and clinical evaluation processes use PMS reports or Periodic Safety Update Reports (PSURs) in their benefit-risk analyses. This ensures the product’s safety throughout its entire lifecycle as well as its clinical performance.
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 for medical devices also involves conducting surveys that enable the collection of structured feedback from users. By selecting and processing these data sources, PMS can provide a comprehensive understanding of user experiences and offer manufacturers a sound, data-driven basis for decision-making to help them optimize their products.
Advantages of a well-designed PMS system
The primary motivation for establishing a well-designed PMS system for medical devices is, of course, compliance with MDR regulations. However, there are other benefits as well. A state-of-the-art, intelligently designed analysis process not only optimizes the use of human resources but also improves the quality of data analysis.
Software tools provide support for automating and streamlining data collection and processing tasks. This reduces the workload and helps prevent errors in repetitive tasks. It also frees up time that employees can use to critically review the available information and prepare meaningful conclusions for reporting.
Cybersecurity in the PMS Process
Our customized PMS service meets the strict requirements of the MDR while providing an accurate overview of your medical device’s safety and performance.
Would you like to establish your own PMS system for planning, data collection, and analysis within your company? Or do you need a reliable partner to create your PMS plan and all safety-class-specific reports for post-market surveillance?
We ensure that you consistently meet all MDR requirements, thereby guaranteeing the safe and effective care of patients.
