Reed Tech — SingleSource for Medical Devices
Reed Tech provides expert UDI data management and submission services for medical device manufacturers, ensuring compliance with global health authorities. They offer SaaS solutions and outsourced services for product data lifecycle management.
LexisNexis Reed Tech, operating as SingleSource for Medical Devices, specializes in managing medical device Unique Device Identification (UDI) product data for global health authorities. They serve a wide range of clients, from small to mid-size producers to the largest global leaders in the pharmaceutical and medical device industries. Their core business revolves around ensuring compliance with UDI regulations. Reed Tech offers a compliant SaaS environment for managing UDI data throughout the product lifecycle, with scalability for increasing volumes and global health authority requirements. They have active UDI channels for the US FDA, China NMPA, South Korea MFDS, and are preparing for EU EUDAMED and Australia UDID. Services include the SingleSource™ UDI Submission SaaS Solution, which allows medical device labelers to manage UDI record submission and product data lifecycle management directly. For organizations with limited resources, the SingleSource™ UDI Premium SaaS Solution provides guided support for UDI submissions. Additionally, they offer GDSN syndication of product data to meet requirements from governmental authorities and buyers. Reed Tech also provides regulatory consulting and outsourced services such as Structured Product Labeling (SPL) for US FDA product listings, eCTD, US Agent services, and other drug listing & establishment registration services. Their expertise in medical device regulatory requirements and UDI data management aims to improve outcomes for healthcare providers and patients.
About
**Who they are**
Reed Tech — SingleSource for Medical Devices is a provider of UDI data management and submission services for medical device manufacturers, ensuring compliance with global health authorities. They offer SaaS solutions and outsourced services for product data lifecycle management.
**Expertise & scope**
* Expert UDI data submission to global health authorities, including US FDA, China NMPA, South Korea MFDS, and staging for EU EUDAMED and Australia UDID.
* Management of UDI data throughout the product lifecycle in a compliant SaaS environment.
* Scalability for increased volume and additional global health authorities.
* Support for FDA GUDID submissions and future UDI regulatory requirements.
* GDSN syndication of product data to meet requirements of governmental authorities, UK NHS eProcurement, buyers, Group Purchasing Organizations (GPOs), and hospital networks.
**Reputation / proof points**
* Submits close to one-quarter of all NLM Access GUDID UDI records annually.
* Represents about 34% of electronic SPL submissions to GUDID.
Reed Tech — SingleSource for Medical Devices is a provider of UDI data management and submission services for medical device manufacturers, ensuring compliance with global health authorities. They offer SaaS solutions and outsourced services for product data lifecycle management.
**Expertise & scope**
* Expert UDI data submission to global health authorities, including US FDA, China NMPA, South Korea MFDS, and staging for EU EUDAMED and Australia UDID.
* Management of UDI data throughout the product lifecycle in a compliant SaaS environment.
* Scalability for increased volume and additional global health authorities.
* Support for FDA GUDID submissions and future UDI regulatory requirements.
* GDSN syndication of product data to meet requirements of governmental authorities, UK NHS eProcurement, buyers, Group Purchasing Organizations (GPOs), and hospital networks.
**Reputation / proof points**
* Submits close to one-quarter of all NLM Access GUDID UDI records annually.
* Represents about 34% of electronic SPL submissions to GUDID.
Additional information
Reed Tech — SingleSource for Medical Devices provides a SaaS environment for managing UDI data throughout the product lifecycle. Their SingleSource™ UDI Premium SaaS Solution offers guided support for UDI record submission, assisting with the process for device labelers with limited staff resources. The service also includes GDSN syndication of product data, which helps organizations meet the requirements of various governmental authorities and other entities.
Key Highlights
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Submits close to one-quarter of all NLM Access GUDID UDI records annually.
Source
“submitting close to one-quarter of all NLM Access GUDID UDI records annually”
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Represents about 34% of electronic SPL submissions to GUDID.
Source
“representing about 34% of electronic SPL submissions to GUDID.”
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Active UDI channels for US FDA, China NMPA, South Korea MFDS and staging for EU EUDAMED and Australia UDID.
Source
“Reed Tech has active UDI channels for US FDA, China NMPA, South Korea MFDS and staging for EU EUDAMED and Australia UDID.”
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SingleSource™ supports FDA GUDID submissions and future UDI regulatory requirements of Global Health Authorities.
Source
“SingleSource™ supports FDA GUDID submissions and future UDI regulatory requirements of Global Health Authorities.”
Certifications & Trust Signals
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LexisNexis Reed Tech is a leading FDA supplier of Unique Device Identification (UDI) information.
Source
“LexisNexis Reed Tech is a leading FDA supplier of Unique Device Identification (UDI) information”
Buyer Snapshot
Best for
- Medical device manufacturers needing UDI data management and submission.
- Companies seeking SaaS solutions for product data lifecycle management.
- Organizations requiring GDSN syndication for product data.
How engagement typically works
- SaaS solutions for self-management.
- Outsourced services for guided support.
- Full-service approach for UDI record submission and management.
Typical deliverables
- Managed UDI data records via a cloud-based solution.
- Accurate product data submissions to regulatory authorities.
- GDSN syndication of product data.
- Compliance with global health authority UDI requirements.
Good to know
- Best when requiring expert support for complex UDI submissions and data management.
HQ:
Horsham, US
Languages:
English
Timezones:
EST
Status:
listed
Services & Capabilities
FDA GUDID Submission Tools
Pricing model:
Monthly subscription
Submission Route:
managed_service
Generates Spl:
Yes
Gdsn Integration:
Yes
Additional gudid_submission_tools Details
Submission Route
managed_service
Generates Spl
Yes
Handles Esgsubmission
Yes
Validation Tools
Yes
Gdsn Integration
Yes
