Solutions
Streamline Medical Device Post-Market Surveillance, Compliance and Research
- Utilize real-world clinical data to support marketing strategies.
- Provide safety and efficacy evidence for healthcare providers and patients.
- Tailor marketing materials with validated clinical data insights.
- Enhance competitive edge by substantiating performance claims.
- Utilize real-world clinical data to support marketing strategies.
- Provide safety and efficacy evidence for healthcare providers and patients.
- Tailor marketing materials with validated clinical data insights.
- Enhance competitive edge by substantiating performance claims.
- Reduce research and development timelines through efficient data utilization.
- Optimize study designs and target cohort stratification.
- Mine unstructured EHR data using advanced Natural Language Processing AI.
- Drive iterative design innovation with data-informed product development insights.
- Address EU MDR and FDA compliance demands with regulation-grade real-world evidence (RWE).
- Reduce regulatory submission time and cost by up to 60%.
- Demonstrate data relevance and reliability with device agnostic validation studies.
- Economize data management and evidence generation with 3Aware's fit-for-purpose platform.
"The EU Legislator now expects higher requirements for sufficient clinical data of all medical devices, ensuring acceptable safety and performance of a device over its expected lifetime; regardless of risk class, complexity, or invasiveness level.
We cannot keep using traditional methods and must instead think differently by using new methods of data linkage for analysis of device-specific electronic patient records; therefore, 3Aware is the real hope for the various frustrated economic operators."
- Ongoing reporting of device utilization and clinical outcomes, including Patient Reported Outcome Measures (PROMs) and EHR imaging.
- Active surveillance of devices for risk signals and new indications.
- Supports continuous improvement and compliance initiatives.
- Scalable solutions for longitudinal data analysis across patient population.
- Monitor adverse effects and device efficacy in real-world settings.
- Utilize aiSurveillance for advanced analytics and reporting.
- Identify failure patterns and reduce risks associated with long-term device use.
- Deliver robust evidence for ongoing safety evaluations and quality assurance.
- Compare new products with legacy devices and market benchmarks.