Post-market surveillance deliverables for IVDs are different throughout the world. Our global can support you with every type of IVD and market. RQM+ is here to help with launching a new product and planning PMS, implementing changes to comply with EU IVDR, or developing correction plans.
Data from post-market surveillance is just part of the story. Accurate data must flow between PMS, performance evaluation reports, and risk management systems, and we have the experience to help you integrate your various systems. Whether you just want a strategy or need our team to successfully implement it, we are here for you.
RQM+ has always been on the leading edge of EU IVDR implementation for all IVD classes. We provide strategy through detailed tactical execution with automated systems, and processes to keep your PMS plans and supporting documents ready for notified body review.
When submission deadlines loom, we will put systems and timelines in place to help align your internal teams. Notified bodies want to see the whole story of your IVDs. Our team will develop methods for consistent data assessment, cross-functional review, and justification when drafting your PMPF plan, conducting activities, and writing reports to paint a clear picture.
When your internal teams are overwhelmed, RQM+ has the technical expertise to develop and execute compliant user surveys focused on demonstrating performance objectives to meet PMPF requirements. We provide the necessary people, processes, and technology to gather the comprehensive data you need to prepare PMPF reports.
From creating your first PMPF plan to remediating documents with nonconformities, our team is here to help. RQM+ uses a performance evidence matrix to identify gaps and weaknesses so you benefit from fewer questions from regulators, shorter review times, and documentation that is clear and consistent.
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