3Aware and RQM+ Forge Partnership to Enhance MedTech Compliance and Innovation

INDIANAPOLIS, IN - October 28, 2024 - 3Aware, a pioneer in real-world evidence (RWE) solutions for the medical device industry, is pleased to announce a strategic partnership with RQM+, a leading global MedTech service provider. This collaboration marks a significant step in enhancing regulatory compliance and fostering innovation within the MedTech sector.

The partnership will combine 3Aware's advanced aiSurveillance technology with RQM+'s comprehensive regulatory expertise to offer an integrated approach to post-market surveillance and compliance for medical device and IVD manufacturers. This synergy aims to transform how companies meet rigorous regulatory requirements while accelerating label expansion and time to market for new and innovative medical devices.

"Joining forces with RQM+ aligns with our mission to optimize device portfolios and simplify the complexities of MedTech compliance," said Bill Moss, CEO at 3Aware. "This partnership will leverage our aiSurveillance platform to its fullest potential, ensuring that our clients not only meet but exceed business objectives and evolving regulatory standards."

RQM+'s extensive experience in global regulatory pathways will enhance 3Aware's offerings, providing clients with a seamless, efficient pathway through clinical evaluation and regulatory submissions. "We are excited to partner with 3Aware to enhance our service offerings. Together, we will provide a strategic advantage to clients, navigating them through regulatory and business challenges with greater efficiency and accuracy," stated John Potthoff, CEO of RQM+.

The partnership will focus on several key areas:

• Regulatory Grade RWE Generation: 3Aware will enable RQM+ to provide clients with full patient EHR records related to a device or group of devices. This approach accelerates study timelines and bridges the gap between RWD-derived clinical research and clear patient outcomes, providing a more comprehensive understanding of how the device(s) are impacting patient care.
• Enhancing Post-Market Clinical Follow-up (PMCF): By integrating RQM+'s regulatory strategies with 3Aware's RWE platform, the partnership will streamline PMCF activities, reducing operational costs and time for MedTech companies.
• Data Management and Analysis: Leveraging 3Aware's capability to extract and analyze complex real-world data, the collaboration will enhance the decision-making process, supporting regulatory submissions and surveillance activities.
• Global Compliance and Market Access: With RQM+'s insight into global regulatory requirements and 3Aware's technology, the partnership will facilitate faster and more efficient market access for medical devices across various international markets.

"This partnership is a testament to our commitment to driving healthcare innovation through regulatory excellence and streamlined data analysis," added Amelia Hufford, PhD, SVP of Clinical & Regulatory Science Operations at 3Aware. "By combining our strengths, we are setting a new standard in the MedTech industry."

About 3Aware

3Aware created a fit-for-purpose analytic platform for the MedTech industry, combining data science and clinical science, to automate highest-quality clinical real-world evidence for Post-Market Clinical Follow-up (PMCF), Label Expansion, Marketing Assertions and more.

• 3Aware integrates real-world data sources such as EHRs and processes vast amounts of patient data, transforming the data into easily assessed patient outcome information.
• 3Aware pinpoints specific devices via UDI numbers and provides access to full patient EHR records, including unstructured notes.
• 3Aware enables MedTech companies to find longitudinal data for Class III implants and procedure-specific clinical evidence for label expansion opportunities.
• 3Aware reduces time and resources dependency, thus accelerating study timelines.

Please visit 3aware.ai for more information.

About RQM+

RQM+ is a leading MedTech service provider accelerating compliance and market success. Through unparalleled expertise and industry knowledge, RQM+ delivers specialized solutions and expedites the journey along the full product lifecycle for medical device and IVD companies, from concept to commercialization to post-market.

The RQM+ portfolio of services enables the delivery of end-to-end solutions across the complete product lifecycle:

• Regulatory and Quality Consulting
• Lab Services and Materials Consulting via Jordi Labs
• Clinical Trials
• Reimbursement
• ai (AI/ML Platform)

Please visit rqmplus.com for more information.

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