{"id":9350,"date":"2026-08-18T11:08:11","date_gmt":"2026-08-18T09:08:11","guid":{"rendered":"https:\/\/www.bayoosoft.com\/?p=9350"},"modified":"2026-08-18T11:10:54","modified_gmt":"2026-08-18T09:10:54","slug":"pms-of-medical-devices","status":"publish","type":"post","link":"https:\/\/www.bayoosoft.com\/en\/bayoosoft-access-manager-en\/pms-of-medical-devices\/","title":{"rendered":"PMS of medical devices"},"content":{"rendered":"

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PMS of medical devices<\/h1><\/div>
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How Post-Market Surveillance (PMS) supports safety and performance<\/h2><\/div>

Since the Medical Device Regulation (MDR)<\/a> 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\u2014from planning to the final report\u2014as part of their desk reviews or audits.<\/p>\n

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\u2014not 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.<\/p>\n

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.<\/p>\n<\/div><\/div><\/div>

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Assess Risks and Identify Untapped Potential with PMS<\/h2><\/h2><\/div>

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\u2019s safety throughout its entire lifecycle as well as its clinical performance.<\/p>\n

PMS also provides valuable insights for the product:<\/p>\n<\/div>