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, specializing 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, specializing 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 focuses on simplifying complex regulatory data submissions. Their expertise in UDI data management and SPL services is designed to help manufacturers navigate global health authority requirements efficiently. For companies entering or operating within the EU market, understanding and complying with EUDAMED regulations is crucial for market access and ongoing compliance.
Key Highlights
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Reed Tech 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 and SPL services for global health authorities.
Source
“specializing in UDI data management and SPL services for global health authorities.”
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Offers coverage for the EU market.
Source
“Coverage: EU”
Certifications & Trust Signals
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Coverage includes the EU.
Source
“Coverage: EU”
Buyer Snapshot
Best for
- Medical device and pharmaceutical companies seeking UDI data management
- Companies needing SPL services for global health authorities
How engagement typically works
- Provider of expert regulatory solutions
- Specialized support for data management and submissions
Typical deliverables
- UDI data management support
- SPL service delivery
- EUDAMED registration support
Good to know
- Best when requiring specialized regulatory expertise for EU markets.
HQ:
Horsham, US
Languages:
English
Timezones:
America/New_York
Claim status:
Listed
Services & Capabilities
Best EUDAMED Registration| Compare & Get Quotes
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, Actor
Supports Actor Registration
true
Supports UDI
true
Supports Vigilance
No
Supports Clinical Investigations
No
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