Medical Device Product Data Management
Reed Tech SingleSource™ for Medical Devices
Easily maintain a master data set and provide accurate product data to regulatory authorities and customers
Health authorities around the globe are developing regional legislation with requirements and timelines for Unique Device Identification (UDI). Simplifying and refining complex compliance and monitoring activities allows professionals in Regulatory Affairs, Quality Assurance and IT roles to focus on the bigger picture. Bringing compliant products to the global market is simplified when you have experienced guidance on the similarities and differences among varying regulators.
How can Reed Tech SingleSource™ for Medical Devices help?
- Achieving Compliance—For EU UDI by 2022 and other global regulatory requirements, you need 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 Global Regulatory Authorities 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.
SingleSource™ for Medical Devices Features
Central Product Data Management
- Store product data in a secure cloud repository
- Ensure master data values are current, accurate and comprehensive
- Assign roles and permissions for corporate and in-country legal representatives
Simple Data Syndication
- Share your latest data with downstream users anywhere
- Quickly react when new compliance requirements arise
- Ensure version control and centralization of data
Traceability & Control
- View audit trails and version history with simple reports
- Ensure harmonization of data with a single, scalable solution
- Retain regulatory authority acknowledgements
Compliance & Security
- Meet 21 CFR Part 11 requirements in a fully verified system
- Access audit trail reports for high-level security
- Change management and version control for role-based permissions
- Get help when you need it from our industry experts
- Gain knowledge of submission process and business rule nuances from region to region
- Count on that ‘last-mile-of-support’ to meet compliance deadlines
EU Medical Device Regulation (MDR) UDI Submission
- Distribute accurate product UDI data to EUDAMED and future Global Health Authorities
- Centralize UDI submissions by selectable channels within the solution
- Transfer accepted data back to internal systems
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 September 24, 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.
Sign up for a demo today.
Questions? We are here to help. Visit our Knowledge Center or Contact Us.