Medical Device Regulatory Compliance Solutions | UDI, IDMP & Global Submissions with LexisNexis Life Sciences

LexisNexis Life Sciences SolutionsMedical Device Solutions
Manage device product data and submit UDI records to global health authorities with confidence.
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LexisNexis Life Sciences Solutions Medical Device Solutions helps manufacturers manage, validate, and submit device product data to global health authorities. It supports compliance, centralized data control, and efficient regulatory submissions across the product lifecycle.

Regulatory ComplianceSimplify UDI submissions

Submit Unique Device Identification (UDI) records to global health authorities with greater efficiency. Centralized tools help manufacturers manage regulatory data and meet submission requirements.

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Global UDI Submissions

Submit UDI records electronically to the U.S. FDA and other global health authorities.

Global UDI Turning Point

Major medical device UDI requirements are taking effect across the EU, Australia, and Switzerland.

Global authority support

Support submissions to regulators like the FDA, EU EUDAMED, China NMPA, Australia AusUDID, Switzerland swissdamed and other global agencies.

Regulatory expertise

Access experienced regulatory specialists who support compliance and submission requirements.

Product Data ManagementCentralize device product data

Maintain accurate and validated device product data within a centralized system. A unified repository improves traceability, governance, and data control.

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Central data repository

Store and manage device product data in a centralized, secure platform.

Data validation controls

Validate device data to ensure accuracy and regulatory readiness before submission.

Data traceability

Track product information across the device lifecycle for improved governance and control.

System integrations

Integrate with existing product information or master data management systems.

Operational EfficiencyImprove regulatory workflows

Streamline the collection, transformation, and submission of regulatory product data. Reduce operational complexity and improve team productivity.

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Data collection

Collect product data required for regulatory reporting and compliance.

Data transformation

Convert regulatory data into the formats required by health authorities.

Regulatory submissions

Submit product data electronically to global regulatory databases.

Compliance tracking

Track regulatory submission progress and manage compliance deadlines.

Supporting ServicesExpand your regulatory support

Explore additional services that help medical device organizations manage regulatory data and maintain UDI compliance across global markets.

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UDI (Unique Device identification) Services

Access expert support to prepare, validate, and submit UDI records to global regulatory authorities while maintaining compliant device data.

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Regulatory Data Management

Organize and maintain structured product and regulatory data to support compliant submissions and ongoing data governance.

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Solutions and capabilities

UDI Data Management

Manage Unique Device Identification (UDI) product data for submission to global health authorities.

Regulatory Data Submissions

Prepare and submit regulatory product data to authorities such as the FDA and EU EUDAMED.

Centralized Data Platform

Maintain device product data in a centralized platform that supports traceability, validation, and governance.

Regulatory Advisory Services

Access regulatory expertise for complex submission requirements and compliance strategies.

Product Data Syndication

Share validated product data with regulators and other stakeholders across the global device ecosystem.

Data Security, Privacy, and Governance

Security and privacy you can count on

Privacy by design

LexisNexis protects customer data wherever it is stored, sent, or accessed. We apply privacy by design principles at every stage of development to ensure security and compliance are built in from the start. Our advanced encryption and rigorous compliance protect your sensitive information. 

Strict security protocols

LexisNexis systems meet the highest standards for information security. We partner with trusted, enterprise-grade cloud providers, continuously monitor and improve our infrastructure,
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Who are LexisNexis Medical Device Regulatory Compliance Solutions for?

A variety of legal, government, corporate, education, and business organizations who need deep investigations of a people, businesses, or property records. Used when preparing for trial, conducting due diligence and running conflict checks, LexisNexis public records is the right choice in any non-FCRA regulated situation where a complete picture of a person, business or asset is required.
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  • Manufacturers
  • Regulatory Affairs
  • Compliance Teams
  • Information Technology
  • Supply Chain

What people are saying

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

Excellent customer and technical support. LexisNexis Life Sciences 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

We are FDA-governed and not an implantable device. We are mainly low-tech, but LexisNexis understood our experience. There is a level of‘human’ that I really appreciate.

Director of Purchasing and Logistics at an optical manufacturer
Frequently asked questions

UDI submissions are regulatory records that identify medical devices and must be submitted to health authorities such as the FDA and other global regulators.

The solution helps manufacturers collect, validate, manage, and submit UDI product data to regulatory databases worldwide.

Regulatory affairs teams, compliance professionals, IT teams, and medical device manufacturers use these solutions to manage regulatory product data and submissions.

Centralized data management improves traceability, ensures data accuracy, and supports regulatory compliance across the product lifecycle.

Health authorities including the U.S. FDA, EU EUDAMED, China NMPA, and others require device identification data to be submitted for regulatory compliance.

Talk to a Life Sciences Regulatory Professional Today

Questions about medical device, pharmaceutical, or cosmetic products or services? We can help.
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Reed Tech is now LexisNexis Life Sciences Solutions

While the Reed Tech name is being retired, the business has long operated as part of LexisNexis. Customers will continue to work with the same regulatory experts, services, and solutions—now unified within LexisNexis Life Sciences to reflect the broader capabilities and global resources of LexisNexis