Medical Devices.
Open the door to the world of medical device data.
Challenge
Medical data becoming more complex
and nuanced
Large amount of data to be ingested,
aggregated and analysed in real-time
Regulatory requirements becoming more
stringent and costly
Lack of medical interoperability of data
Rapidly evolving digital landscape requires
more Integrated approaches
Solution
Management of all pre and post market data
from medical devices. With one single system
Ensured compliance with requirements such as
EU MDR. Already at the time of first data entry
Direct integration of device data into ePRO and EHR.
Medical interoperability during entire device life cycle
Access to real world evidence.
For better patient safety
Decentralized Trial Support.
Cost efficient and fast to market
Oomnia EDC/CTMS is uniquely flexible and adaptable to your needs. Perform your medical device clinical evaluation, access data from your device in real-time, and enhance the post market surveillance. It is built to empower people, processes, and progress.
Medical Device Data Management
Medical Device Data Management
Unlock the unlimited potential of your medical device data.
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Medical Device Trial Support
Medical Device Trial Support
Enhance your device capabilities with medical writing and biostatistics expertise.
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Professional Services
Pharmacovigilance
CE Marking
CE Marking
Obtain your CE mark efficiently with compliant and streamlined data processes.
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Post Market Surveillance (PMS, PMCF)
Post Market Surveillance (PMS, PMCF)
Track your device performance through the entire lifecycle.
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Technology Solutions
Oomnia EDC/CTMS
Oomnia EDC/CTMS
A cloud based, robust and scalable solution for your medical device data capture.
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SmartReports
SmartReports
Real-time medical device data capture and presentation with advanced analytics.
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Medical Device Connectivity
Medical Device Connectivity
Create new digital assets by connecting your medical devices to traditional frameworks.
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Benefits
100%
Medical Data
Reusability
-50%
Data Management
Related Costs
-50%
Time
To Market
100%
Fully
Compliant
100%
HIS/EHR/ePRO
Integration
- All metrics calculations based on data received from our clients
