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Regulatus has announced a new partnership with LexisNexis Reed Tech to help medical device manufacturers tackle the growing complexity of EU MDR/IVDR and EUDAMED requirements.
At the core of the collaboration is SingleSource for Medical Devices, a secure, cloud-based platform that centralises UDI (Unique Device Identification) data. The system enables companies to manage, validate, and submit regulatory information more efficiently, replacing fragmented processes like spreadsheets and manual uploads with a single, structured source of truth.With built-in validation and lifecycle tracking, SingleSource helps improve submission accuracy and reduce the risk of delays or rejections, while also supporting global regulatory requirements.
Regulatus will deliver a fully managed service alongside the platform, handling UDI data preparation, validation, and submission to EUDAMED. This ensures ongoing compliance as product portfolios evolve, backed by regulatory expertise and complete audit readiness.The partnership reflects a wider industry shift toward smarter, technology-driven compliance, helping manufacturers save time, reduce risk, and focus on innovation.
We've already onboarded customers to help save them valuable time of not only uploading, but management of errors, updates, and removal and adding of SKU's and products.
You can read more about Regulatus+ and our further offerings including EUDAMED bulk upload and management here: Regulatus + - Regulatory Compliance Support Tools
