We offer comprehensive post-market surveillance support that integrates risk management and clinical requirements.
RQM+ delivers a risk-balanced approach to post-market activities to support your business goals. From creating your PMS plan to retroactive PMCF studies and writing reports, we have the resources and solutions to help you stay compliant while simultaneously creating processes and incorporating efficiencies.

RQM+ can help with specific PMS tasks or provide fully managed services.

    PMS tasks

Post-market surveillance deliverables for medical devices vary depending on the market. Our global team has experience with every type of device and every regional regulation. Whether you are launching a new product, transitioning to EU MDR, or need a correction plan, our team is here to help.

We know that data from post-market surveillance is just part of the story and understand the importance of accurate data flow between PMS, clinical evaluation reports, and risk management systems. We’ll create a strategy for integrating all of your systems and help you successfully implement it. 

Our global team is comprised of engineers and scientists who understand how medical devices work, how performance is measured, and what type of documentation and evidence is required. With former regulators and notified bodies on staff, we have unique insights into how regulatory bodies and reviewers are likely to respond.

We’ll help align your internal teams and put systems and timelines in place to meet submission deadlines. We know that notified bodies want to see the whole story, so we’ll develop methods for consistent data assessment, cross-functional review, and justification when drafting your PMCF plan and reports.

Learn more about Post-Market Clinical Follow-up

Developing and executing compliant user surveys requires technical expertise and time that not all manufacturers have. RQM+ provides the necessary resources—including people, processes, and technology— to gather the clinically meaningful and scientifically valid user surveys you need to prepare PMCF reports.

Whether you are creating your first PMCF plan or need to remediate documents with nonconformities, RQM+ uses a clinical evidence matrix to identify and fill gaps. The results are fewer questions from regulators, shorter review times, and clarity and consistency across all documentation. 

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SME Support

SME Support

When our SMEs create surveys, analyze data, or write reports, they look at the whole picture to ensure all of your documents are consistent.

Technical Leadership

Technical Leadership

If you need technical leadership in specific PMS areas, we’ll work closely with you to define the scope and provide subject matter experts to lead your team through complex situations.

Full Service PMS Support

Full Service PMS Support

From creating and executing post-market surveillance plans to training your staff and providing ongoing support, we can handle every aspect of your PMS needs.

We do more than create plans and write reports. When you work with RQM+, we’re an extension of your business.

Learn more about the RQM+ approach

Our most successful relationships are the strategic partnerships that allow us to add value to your business.

Ongoing PMS Support

Post-market surveillance is not a one-time activity; it’s an ongoing process that must be maintained. Our team can help you with data trending, report updates, and maintenance of your risk management files based on post-market data.

Learn more about creating PSURs

Complete MDR Transition

Although RQM+ can contribute to specific elements of the technical documentation for your medical devices, it works best when we’re involved with every aspect. Post-market surveillance is just one part of the story notified bodies want to see, and without quality documentation every step of the way, it’s difficult to share the full picture of a safe and effective device. Our integrated approach reduces time to certification with fewer questions and nonconformities.

Learn more about MDR Planning & Execution

Gap Assessments and Systems Integration

We understand that data doesn’t always flow seamlessly between risk management, clinical, and post-market surveillance systems. We also understand how everything fits together and have the tools and expertise to integrate these essential elements.

Learn more about Quality System Integration

Managing every aspect of post-market surveillance and ensuring that all of the components fit together is a challenge all medical device manufacturers face. We’ll collaborate with you to fill the gaps and build in-house skills and capabilities to deliver transformative solutions.

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Strategic Guidance
We offer a unique combination of deep clinical and regulatory expertise.

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Risk-Balanced Approach
We balance regulatory and clinical requirements with business needs and risks.

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Industry Experience
Having former notified body leadership on staff provides insight into reviewer expectations.

Explore Post-Market Surveillance for Medical Devices by Region

Post-Market Surveillance for Medical Devices in the US

From creating and implementing tracking systems to generating all of the studies and documentation required under section 522, RQM+ has skilled resources to help you stay compliant after your devices are on the market.

Post-Market Surveillance for Medical Devices in the EU

Requirements for post-market surveillance deliverables have grown dramatically in the EU since the implementation of the MDR. RQM+ has extensive thought leadership and experience creating PMS plans, PMS reports, PMCF plans, and PSURs along with the development and execution of user surveys. Successful integration of PMS, CERs, and risk management is a key to success, and we have the expertise to help you do it.

Global Post-Market Surveillance for Medical Devices

Our global team has experience in post-market surveillance for products launched in a wide variety of markets. If you need support after you have launched a medical device 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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