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.
LexisNexis SingleSource Medical Device Product Data Management
LexisNexis SingleSource™ for Medical DevicesMedical Device Product Data ManagementHow can SingleSource™ for Medical Devices help manage the complexities of UDI for multiple global health authorities?
Our core business is managing and submitting Unique Device Identification (UDI) data. Starting with the US FDA, medical device regulators are instituting UDI compliance requirements in regional markets around the world. Numerous Health Authorities, including the European Commission (EUDAMED), China NMPA, South Korea MFDS and Australia TGA/AusUDID have issued regulations with more to follow.
Medical device manufacturers are finding that UDI implementation can be difficult. The regulations are new, with varying levels of clarity and they are not harmonized. They have differing legislation, policy, timing, data and submission approaches. For teams managing UDI regulatory data, the preparation, collection, submission and maintenance details can quickly become a complex and overwhelming task.
SingleSource™ centralizes UDI submissions data in a single, flexible solution. Start with the regions your devices are marketed in and that accommodate machine-to-machine submissions. Activate and pay for channels when you enter a market, not assumed within a bundled rate. Plus, receive training and continual UDI educational opportunities as new information is published by Health Authorities.
What can SingleSource™ for Medical Devices do for your team?
The Challenge
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.
Subject-Matter Expertise
To navigate, understand, and react is a necessity.
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.
Learn more about approaches to managing UDI product data
SingleSource™ for Medical Devices Features
- 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
- Share your latest data with downstream users anywhere
- Quickly react when new compliance requirements arise
- Ensure version control and centralization of data
- View audit trails and version history with simple reports
- Ensure harmonization of data with a single, scalable solution
- Retain regulatory authority acknowledgements
- Meet 21 CFR Part 11 and EU Annex 11 technical 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
- Distribute accurate product UDI data to EUDAMED for MDR/IVDR
- Test UDI product data for future Global Health Authorities
- Centralize UDI submissions by selectable channels within the solution
- Transfer accepted data back to internal systems
Speak to a Subject-Matter Expert
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.
Sign up for a demo today.
“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
Health Authorities and UDI Requirements
Reed Tech is now LexisNexis Life Sciences Solutions
While the Reed Tech name is being retired, the business has long operated as part of LexisNexis. Customers will continue to work with the same regulatory experts, services, and solutions—now unified within LexisNexis Life Sciences to reflect the broader capabilities and global resources of LexisNexis
Contact LexisNexis Life Sciences
Talk to a Life Sciences Regulatory Professional Today
Questions about medical device, pharmaceutical, or cosmetic products or services? We can help.
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A LexisNexis regulatory expert will reach out soon.
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