We’re excited to announce that B. Braun, a leading medical technology company, has successfully implemented Innovit’s EUDAMED Connector for device submission to EUDAMED. This end-to-end solution enables the onboarding of data from SAP, data conversion and data validation based on EUDAMED rules, and automated data submission to EUDAMED.
Here’s how it works:
- Data Onboarding: Critical device data, including product specifications, classifications, and marketing information, is extracted directly from B. Braun’s SAP ERP system and onboarded into Innovit EUDAMED Connector.
- Data Conversion and Validation: Within Innovit EUDAMED Connector, the source data is automatically mapped and converted to EUDAMED’s data types and attributes, which come out-of-the-box with the application. Pre-packaged and robust data validation rules in Innovit EUDAMED Connector ensure that all submissions adhere to the strict data quality and format requirements mandated by EUDAMED.
- Automated Submission: The validated data is then automatically transmitted to EUDAMED via a secure and reliable connection using the AS4 messaging protocol in the required SOAP XML format.
- Real-time Monitoring: Innovit’s platform provides real-time monitoring of submissions and corresponding responses, allowing for immediate identification and resolution of any issues.
This successful implementation demonstrates the ease of deployment, usability and robustness of Innovit’s EUDAMED Connector. By automating data submission and ensuring data quality, B. Braun was able to achieve:
- Increased Efficiency: Automated data submissions, reducing manual effort and minimizing human error.
- Improved Data Quality: Validated and consistent data submissions, minimizing the risk of errors and rejections.
- Enhanced Compliance: Timely compliance with EUDAMED regulations and reduced risk of non-compliance penalties.
At Innovit, we are committed to providing cutting-edge solutions that empower medical device manufacturers to navigate the complexities of the regulatory landscape, while leveraging their trusted product data to optimize their internal business processes.
