3Aware

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3Aware transforms real-world clinical data into actionable insights, enabling MedTech companies to: 1. Track Device Safety and Performance 2. Streamline Regulatory Compliance 3. Expand Market Access 4. Inform Product Development We empower medical device manufacturers to optimize total product lifecycle with less cost, time and risk... and more knowledge. 3Aware Solutions: > Post-Market Clinical Follow-Up (PMCF): Fulfill regulatory requirements with high quality and highly relevant real-world evidence... at a fraction of the time, cost and risk of traditional methods. > Label Expansion: Expand market reach with substantiated evidence. > Marketing Assertions: Support product claims with validated clinical proof. > Longitudinal Surveillance: Monitor long-term clinical outcomes tied to specific devices, in a fit-for-purpose analytic platform. > Informed Product R&D: Drive innovation with real-world data-backed insights. > Regulatory Compliance: Navigate EU MDR and FDA regulations more quickly and cost-effectively, with lower buyer risk. > Safety & Performance: Enhance patient safety and device efficacy through detailed performance analysis and proactive monitoring.

Company Details

Employees
31
Founded
-
Address
6100 Technology Center Dr, Indianapolis,indiana 46278,united States
Industry
Software Development
Website
http://www.3aware.ai
Keywords
RWD, PMS, PMCF, Total Product Lifecycle, Real-World Data, Real-World Evidence, RWE, Post-Market Clinical Follow-up, FDA, Medical Devices, SaaS, Label Expansion, EU MDR, Post-Market Surveillance, Marketing Assertions, Product Development, Market Access, aiSurveillance.
HQ
Indianapolis, Indiana
Competitors
Stryker, Ryght AI, RQM+, Orr Fellowship, ACCUMEN, hc1, RALLY, DecisionRx, Inc., Qualio, Health Cloud Capital.
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