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Medical Device Data Management & Syndication

Medical Device Data Management & Syndication

Unique Device Identifier Services (UDI) – FDA GUDID

Easily maintain a master data set and provide accurate product data to regulatory authorities and customers

SingleSource™ for Medical Devices

The SingleSource system is a Reed Tech hosted, online repository with governance and controls for data quality, data integrity and data security. This global solution can seamlessly act as a “single source of truth”.

UDI SaaS Solution

The Reed Tech UDI SaaS Solution is built for device labelers that want to build and submit UDI records electronically to the FDA in Structured Product Labeling (SPL) format and efficiently maintain those records throughout their lifecycle. The cloud-based tool allows labelers to directly manage all phases of the process: Data Collection and Capture, Validation, SPL UDI Record Preparation, Submission and Ongoing Maintenance.

UDI Premium SaaS Service Solution

The Reed Tech UDI Premium SaaS Service is designed for device labelers who are seeking an experienced UDI data submission partner to help. Expert Reed Tech staff work with your regulatory team to smoothly navigate each stage of UDI data submission. This model is ideal for labelers who have limited staff resources to devote to UDI data compliance.

Global Data Synchronization Network (GDSN) Connection

The Reed Tech GDSN connection integrates the data exchange capabilities of 1WorldSync™, the leading provider of product content solutions, with Reed Tech product data management solutions.

Download EUDAMED Delay Fact Sheet

Reed Tech SingleSource™
for Medical Devices supporting Global UDI

For medical device manufacturers, Reed Tech provides UDI specific solutions, services and expertise, reducing the internal burden in navigating the required business rules for validating, managing and submitting to regulatory agencies.

Using experience gained over a decade as a leading FDA supplier of UDI information (submitting close to one-quarter of all industry UDI records), Reed Tech designed the SingleSource for Medical Devices system. SingleSource allows for managing UDI data throughout the product lifecycle in a compliant SaaS environment and includes scalability for additional volume and data channels.

The UDI must contain a device identifier and a product identifier. The device identifier is a designated portion that denotes the device labeler and the specific model or version of a device. The device identifier is fixed by the device manufacturer. The product identifier is more variable and should identify either the expiration date, the serial number, the manufactured date, expiration date, or the lot/batch number the product was manufactured in. The product identifier can identify as many of the previously listed attributes as desired but must identify at least one. The UDI must be listed in a way that is readable by humans and in a way that automatic identification and data capture technology machines can use. If all of this sounds confusing, Reed Tech is here to help.

As the number of global entities requiring medical device UDI information grows, Reed Tech will add selectable channels for data submission to regulatory bodies and data syndication to commercial trading partners. Strategic product data management supported by a deep understanding of medical device regulatory and user UDI data requirements will ultimately contribute to improved outcomes for both healthcare providers and patients.

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Excellent customer and technical support. ReedTech is a true partner – an extension of our internal resources. Their software solutions are enabling us to successfully meet UDI compliance dates in the US and UK.

– Regulatory Director at a premier provider of infection prevention and other procedural products and services

Use Case Data Sheets for Global UDI

UDI SaaS Solution

Manage UDI data records with a cloud-based solution

The Reed Tech UDI SaaS Solution is a web-based application that allows medical device companies to collect and validate their UDI data, build UDI records in HL7 Structured Product Labeling (SPL) format and submit electronically to the FDA’s Global Unique Device Identifier Database (GUDID). The tool will also allow for submissions to other regulatory authorities outside the U.S. as UDI mandates become prevalent across the globe.

The Reed Tech UDI SaaS Solution has been built for device labelers who wish to equip their regulatory/compliance staff with a robust tool for UDI record submissions and lifecycle management.

  • Multi-Function Solution: Data Collection/Capture/Validation, SPL Preparation, Submission and Management
  • Dual Data Validation based on up-to-date FDA Business Rules and Industry Controlled Vocabularies
  • ISO 9001:2008-certified secure environment; System meets 21 CFR Part 11 technical requirements. Interface to existing systems: PLM, MDM, ERP, RA and more
  • Expandable to support submissions to regulatory authorities outside the U.S.

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UDI Premium SaaS Service Solution

A full-service approach to UDI record submission and management

The Reed Tech UDI Premium SaaS Solution is designed for device labelers with limited staff resources to dedicate to UDI record management or a desire to augment their efforts with additional support from an experienced submissions partner.

Experienced Reed Tech staff help device labelers to collect and validate their UDI data, build UDI records in HL7 Structured Product Labeling (SPL) format, submit electronically to the FDA’s Global Unique Device Identifier Database (GUDID) and perform ongoing record lifecycle management. The Premium service will also support submissions to regulatory authorities outside the U.S. as UDI mandates take shape across the globe.

  • Submission support from dedicated Reed Tech Life Sciences staff
  • Seasoned submission partner with over a decade of SPL experience
  • Multi-Function Solution: Data Collection/Capture/Validation, SPL Preparation, Submission and Management

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Global Data Synchronization Network (GDSN) Connection

A full-service approach to syndicate product data in collaboration with 1WorldSync™

The Reed Tech GDSN connection integrates the data exchange capabilities of 1WorldSync, the leading provider of product content solutions, with the Reed Tech product data management solutions.

GDSN syndication of product data allows device organizations to meet the requirements of governmental authorities, including UK NHS eProcurement and buyers, Group Purchasing Organizations (GPOs) and influential hospital networks.

  • Share medical device product data with trading partners through the Global Data Synchronization Network (GDSN)
  • Fulfill United Kingdom National Health Service eProcurement requirements
  • Provide product data to customers, including Group Purchasing Organizations (GPOs)
  • Meet contractual obligations of influential hospital networks

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UDI: How do I assign Device Identifiers?

Global UDI Summary

EU EUDAMED Delayed-What to do now

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