We offer all-encompassing post-market surveillance support that balances risk management and performance requirements.
The RQM+ approach to post-market activities balances risk with supporting your business goals. Services include creating your PMS plan and writing reports, but we go beyond delivering on tasks. We help you stay compliant and create process efficiencies at the same time.

RQM+ can support specific PMS tasks or provide full managed services.

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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.

RQM+ approach
SME Support

SME Support

When our SMEs  analyze data and create reports, they look at the entire picture to ensure document consistency and alignment.

Technical Management

Technical Management

When you need technical leadership for specific post-market surveillance tasks, we provide subject matter experts to lead your team through complex situations.

Full Service PMS Solutions

Full Service PMS Solutions

We can handle every aspect of your PMS needs, including creating and executing post-market surveillance plans, reports, and PSURs, in addition to training your staff and providing ongoing support.

We go beyond creating plans and writing reports. We are an extension of your business.

Learn more about the RQM+ approach

For RQM+, a successful relationship is a strategic partnership in which we add value to your business.

Ongoing PMS Support

Post-market surveillance is an ongoing process that must be sustained as long as your products are available to patients. The experts at RQM+ can identify data trends, update reports, and maintain your risk management files based on post-market data.

Complete IVDR Transition

RQM+ can support specific elements of the technical documentation for your IVDs, but we see the most success when we are involved with every aspect. Post-market surveillance is just one page of the story, and without quality documentation at every step, it is difficult to share the full picture of a safe and effective product. Our integrated approach reduces time to certification with fewer questions from notified bodies and minimal nonconformities.

Learn more about IVDR Planning & Execution

Gap Assessments and Systems Integration

We know that the data flow between risk management, performance, and post-market surveillance systems isn’t always seamless. We also understand how to integrate these essential elements and have the tools and expertise to do it efficiently.

Learn more about Quality System Integration

There is no doubt managing every detail of post-market surveillance and ensuring that all of the components work together is challenging for IVD manufacturers. We will collaborate with you to identify and fill gaps and deliver transformative solutions by building in-house skills and capabilities.

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Strategic Guidance
The RQM+ team provides a unique combination of deep IVD understanding and regulatory

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Risk-Balanced Approach
We balance regulatory, IVD performance and risks, and business needs to support your goals.

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Industry Experience
Having former notified body leadership on staff helps us understand reviewer expectations.

Explore Post-Market Surveillance for IVDs by Region

Post-Market Surveillance for IVDs in the US

RQM+ provides a skilled team to help ensure compliance after your devices are on the market. Services include creating and implementing tracking systems and generating all of the studies and documentation required under section 522.

Post-Market Surveillance for IVDs in the EU

Thanks to the IVDR, post-market surveillance deliverable requirements have grown dramatically in the EU. The RQM+ team provides extensive thought leadership and has deep experience creating PMS and PMPF plans, and PSURS. We have the expertise to help you successfully integrate PMS, PERs, and risk management.

Global Post-Market Surveillance for IVDs

RQM+ has experience in post-market surveillance for IVD products launched in a wide variety of global markets. If you need support after you have launched an IVD in a new country, our team can help you stay compliant with the relevant regulations.

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

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