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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 CERs and your PMCF plan. RQM+ delivers integrated services to ensure that data from PMCF inputs (IFUs, PMS data, and CER) gets fed into PSUR, CER, and PMCF reports.
When reviewers look at a PSUR, they want to see a complete picture of the safety of your device 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.
Learn how to create a compliant Periodic Safety Update Report (PSUR) under EU MDR and IVDR.
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 CER share information that can be leveraged in the PMCF planning process. Information from the PSUR and CER gets fed into the SSCP and PMCF plan. Then, after PMCF activity, the data gets summarized in the next PSUR and CER 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 Clinical Follow-up
Learn about Quality System Integration
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