Facing the Upcoming Tsunami of Global Med Device Regulations
In the increasingly complex world of medical device regulations, manufacturers need a flexible regulatory data submission tool that will rapidly adapt to not just the upcoming EU MDR EUDAMED submission process, but all impending global regulatory submissions. The first step to this is access to accurate, trusted product data.
The Soom platform creates a data fabric layer that sits on top of enterprise systems ensuring data being transacted between systems is timely and accurate. Rather than creating a new transformed source of truth for data, which is rapidly out of date, Soom utilizes existing data sources to access the most accurate and trusted data. As data sources grow through acquisition, the Soom platform easily integrates without custom coding and transformation engagements.
Soom Data Fabric for Regulatory Data Submission
The traditional solution for data submission to regulatory databases was the creation of custom software rules, transformed data and hardcoded submission tools. This rigid approach is failing to scale for the impending EU MDR EUDAMED submissions and beyond. Custom integrations and middleware do not scale and are expensive to maintain.
As part of the Soom platform, the regulatory data submission workflow features US FDA GUDID submission tool sets that will translate to a EUDAMED submission service. As specifications for EUDAMED and other country regulations continue to be released, the Soom Regulatory Data Submissions workflow is upgraded to reflect the latest regulation changes.