Reed Tech
Reed Tech provides expert regulatory solutions for medical device and pharmaceutical companies, specializing in UDI data management and SPL services for global health authorities.
LexisNexis Reed Tech is a leading provider of information-based solutions and services for the Life Sciences industry. They specialize in managing medical device Unique Device Identification (UDI) product data for global health authorities, offering expertise in UDI data submission and product lifecycle management. Their services include outsourced Structured Product Labeling (SPL) for US FDA product listings, eCTD, US Agent services, and other drug listing & establishment registration services. Reed Tech serves a wide range of clients, from small to mid-size producers and distributors to the largest global leaders in the pharmaceutical and medical device sectors. With a focus on regulatory compliance and data accuracy, Reed Tech's SingleSource™ platform for Medical Devices ensures UDI data is managed in a compliant SaaS environment, with scalability for increased volume and global health authorities. They actively support UDI channels for US FDA, China NMPA, South Korea MFDS, and are staging for EU EUDAMED and Australia UDID, demonstrating their commitment to global regulatory support.
About
**Who they are**
Reed Tech provides expert regulatory solutions for medical device and pharmaceutical companies. They specialize in UDI data management and SPL services for global health authorities.
**Expertise & scope**
* UDI data management
* SPL services for global health authorities
* Regulatory solutions for medical device and pharmaceutical companies
**Reputation / proof points**
* Coverage: EU
Reed Tech provides expert regulatory solutions for medical device and pharmaceutical companies. They specialize in UDI data management and SPL services for global health authorities.
**Expertise & scope**
* UDI data management
* SPL services for global health authorities
* Regulatory solutions for medical device and pharmaceutical companies
**Reputation / proof points**
* Coverage: EU
Additional information
Reed Tech's focus on UDI data management and SPL services positions them as a key partner for companies navigating global health authority submissions. Their expertise is particularly relevant for medical device and pharmaceutical manufacturers requiring accurate and compliant data handling.
Key Highlights
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Provides expert regulatory solutions for medical device and pharmaceutical companies.
Source
“Reed Tech provides expert regulatory solutions for medical device and pharmaceutical companies”
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Specializes in UDI data management.
Source
“specializing in UDI data management”
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Offers SPL services for global health authorities.
Source
“and SPL services for global health authorities.”
Certifications & Trust Signals
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Coverage includes the EU market.
Source
“Coverage: EU”
Buyer Snapshot
Best for
- Companies needing UDI data management
- Manufacturers requiring SPL services
How engagement typically works
- Expert regulatory consultation
- Data management support
Typical deliverables
- UDI data submissions
- SPL data submissions
Good to know
- Best when requiring specialized regulatory support for medical devices and pharmaceuticals.
HQ:
Horsham, US
Languages:
English
Timezones:
America/New_York
Claim status:
Listed
Services & Capabilities
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Jurisdictions:
EU
Countries:
DE, AT, IE, SE, DK, FR, ES
Industries:
Medical devices, IVD, SaMD, Manufacturing
Portfolio:
100+
Onboarding time:
2–14 days
Pricing model:
Retainer
Starting from:
USD 6,000
Included services:
Actor/SRN registration support, UDI/Device module readiness, Data preparation & validation, Training enablement
Supports Actor Registration:
Yes
Supports UDI:
Yes
Supports Data Load:
Yes
Modules Supported:
UDI/Devices
Supports Training Enablement:
No
Data Load Support Level:
Done-for-you
Turnaround SLA:
Custom
eifu_platform
eudamed_onboarding_support
Additional eudamed_reg_support Details
Included Services Detailed
Actor/SRN registration readiness review and submission support (seed scope), UDI/Device data preparation, validation, and upload workflow support (seed scope), Internal data governance mapping (roles, owners, approvals) (seed scope), Training enablement for EUDAMED operational tasks (seed scope)
Excluded Services
Notified Body services or conformity assessment decision-making, Legal representation with Competent Authorities, Clinical evaluation or performance evaluation writing (unless separately scoped)
Onboarding Steps
No specific onboarding steps mentioned.
Data Load Notes
Data load support level indicates whether uploads are done-for-you, guided, or training-only (seed summary).
Modules Supported
UDI/Devices
Supports Actor Registration
Yes
Supports UDI
Yes
Supports Vigilance
No
Supports Clinical Investigations
No
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