Medical Device Product Data Management
Reed Tech SingleSource™ for Medical Devices
What can Reed Tech SingleSource™ for Medical Devices do for your team?
Achieving Compliance—For all the health authority channels with regulatory requirements, engage with UDI expertise with a single, scalable, and flexible solution to collect, maintain, validate, and submit product data.
Utilizing an In-Country Legal Representative—Assign roles/responsibilities for corporate users and local affiliates for a shared team view into UDI data. Avoid multiple costs and provide transparency.
Maximizing Efforts—One ‘source of truth’ is needed to comply with health authority channels, anticipating differing product attributes, data validation rules and submission standards by country.
Sharing Consistent Data—Commercial Trading Partners within the supply chain will require the same product data set used for regulatory submission either via the global data pool or other means.
Trusted Expertise—The electronic submission process and business rules carry nuances from region to region.
Cost Predictability—Protect your budget with a single solution when new regulatory authorities come into the picture. Ensure business continuity is achieved with minimal disruption.
Subject-Matter Expertise—to navigate, understand, and react is a necessity.
Learn more about approaches to managing UDI product data
Health Authorities and UDI Requirements
UDI in the U.S. FDA GUDID
Class I devices and devices that have not been classified into Class I, II or III must submit product data to the FDA’s GUDID by December 8, 2022 (Final Guidance posted July 22, 2022)
UDI in the European Union
Learn more about the data attributes, regulatory, legislation, and distinct differences between FDA GUDID and EU EUDAMED
Health Authorities in Asia
Resources for understanding Unique Device Identification (UDI) regulatory requirements in Asia including China and South Korea
“We were guided through the process step by step, and when we encountered an issue it was resolved promptly.”
-Operations Head for distributor of medical device supplies
SingleSource™ for Medical Devices
SingleSource™ for Medical Devices was built to meet the product data management needs of Medical Device manufacturers. See what it can do for you.
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