Medical Device Product Data Management

Reed Tech SingleSource™ for Medical Devices

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How can Reed Tech SingleSource™ for Medical Devices help manage the complexities of UDI for multiple global health authorities?

Starting with the US FDA, medical device regulators are instituting Unique Device Identification (UDI) compliance requirements in regional markets around the world. Numerous health authorities, including the European Commission, China NMPA, South Korea MFDS and Netherlands LIR 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 burdensome task.

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What can Reed Tech SingleSource™ for Medical Devices do for your team?

The Challenge

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.

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
Expert Support
  • 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

US FDA GUDID

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

EU UDI submissions at Reed Tech

UDI in the European Union

Learn more about the data attributes, regulatory, legislation, and distinct differences between FDA GUDID and EU EUDAMED

China UDI submissions at Reed Tech

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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