Thought Leadership That Extends to Practical PSUR Implementation

Former notified body experience on the RQM+ team gives us unique insights into what reviewers want in a PSUR.

  • An Integrated Approach to PMS Reports and PSURs

    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.

  • Thorough and Extensive Data Collection

    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-Depth Analysis

    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 more about how RQM+ creates compliant PSURs.

  • RQM+ Ties It All Together

    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)

We are passionate about your success. Tell us more about your regulatory and quality needs so we can help.

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