The requirement for a periodic safety update report (PSUR) is new under the EU IVDR. Many manufacturers are struggling to allocate the necessary resources for full IVDR implementation, including post-market surveillance activities such as PSURs. RQM+ has the systems, tools, and industry expertise to ensure your PSURs are compliant and submitted on time.
"RQM+ continues to perform at a high level. I'm beyond pleased with the results thus far as well as the partnership." [in reference to completion of PSURs]
- Senior Director, Head Global Device Complaint Management, Multinational Medical Device Manufacturer
PSURs must collate and evaluate data from multiple systems and sources. Our team will gather and analyze complaint data, adverse events, serious incidents, product usage for all types of devices, CAPAs, FSCAs, recalls, and data from public databases for relevant information about similar devices.
Based on the available data, our expert team will craft a report that includes key elements such as PMS data, a rationale and description of any corrective actions taken, vigilance reporting, current market status, a comprehensive review of the risk-benefit analysis, conclusions of the risk-benefit determination, and summarize any PMPF findings.
PSURs are intended to improve IVD design and patient outcomes, so it’s critical that all relevant conclusions from these reports are fed into your risk management system. RQM+ understands how it all ties together and will work with your team to ensure efficient integration of systems.
Certain IVD classes require annual or biennial PSUR updates. We can handle ongoing maintenance of your entire portfolio to ensure that PSURs across all of your product lines are updated as new information becomes available and submitted in a timely manner to ensure compliance.
The intent behind the requirement for PMS Reports and PSURs is to improve devices and the benefits they offer to patients. We help you meet this goal by ensuring that all of your systems are integrated and that PSURs align with PERs and your PMPF plan. RQM+ delivers integrated services to ensure that data from PMPF inputs (IFUs, PMS data, and PER) gets fed into PSUR, PER, and PMPF reports.
When reviewers look at a PSUR, they want to see a complete picture of the safety of your IVD that aligns with post-market activities and your risk management file. RQM+ will delve into all of your various systems, including PMS, quality, and risk management, to gather and normalize all of the relevant data.
In our experience with PMS Report and PSUR submissions under MDR, data analysis is one of the most important elements—and one of the biggest gaps. If your reports are missing this, you can expect reviewer questions. RQM+ can analyze data from multiple sources to identify trends in adverse events and recalls.
When done right, PMS Reports and PSURs are part of a feedback loop to ensure that all of your documentation is consistent and that the PSUR and PER share information that can be leveraged in the PMPF planning process. Information from the PSUR and PER gets fed into the SSCP and PMPF plan. Then, after PMPF activity, the data gets summarized in the next PSUR and PER to create a continuous feedback loop. If product issues arise, the risk file may need to be updated after the PSUR as well. When you work with RQM+, you can rely on our team to create and implement a plan for cross-functional integration.
PMS support that goes beyond report writing.
While it’s certainly possible to task RQM+ with writing individual reports or handling piecemeal elements of post-market surveillance requirements, our clients see the most success when we are brought in as a strategic partner.
Learn about Post-Market Performance Follow-up
Learn about Quality System Integration
Learn about Performance Evaluation Plans and Reports (PEPs and PERs)
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