SingleSource™for Medical Devices

MedTech Regulatory Compliance
We help companies develop, implement and remediate UDI compliance systems
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How can LexisNexis Life Sciences Solutions help?

We serve almost half of world’s top thirty medical device manufacturers with solutions and services tailored to the niche needs of medical device compliance for Unique Device Identification (UDI). We have expanded our offerings to include a variety of specialized compliance tasks. With dedicated regulatory professionals guiding your team on new or nuanced health authority regulations, Life Sciences Solutions can help you implement cost-effective strategies to accomplish compliance obligations.

Often, regulatory enforcement actions are due to a breakdown in compliance systems, where the right resources are limited or a quality culture reinforcement is needed. MedTech Regulatory Compliance from Life Sciences Solutions is here to help.

Predictable budgeting

Ongoing expert access

Comprehensive service range

What regulatory help should your team be considering?

We serve almost half of world’s top thirty medical device manufacturers with solutions and services tailored to the niche needs of medical device compliance for Unique Device Identification (UDI). We have expanded our offerings to include a variety of specialized compliance tasks. With dedicated regulatory professionals guiding your team on new or nuanced health authority regulations, Life Sciences Solutions can help you implement cost-effective strategies to accomplish compliance obligations. Often, regulatory enforcement actions are due to a breakdown in compliance systems, where the right resources are limited or a quality culture reinforcement is needed. MedTech Regulatory Compliance from Life Sciences Solutions is here to help.

  • General UDI and Device Registration
  • Data Management
  • Custom Business Analytic Reporting
  • API Integration
  • UDI Compliance Training
  • Regulatory Compliance Advisory Services
  • Gap assessment and compliance risk assessment
  • Global UDI support
  • Address data element and other nuances for submissions to US FDA, EU EUDAMED, South Korea IMDIS, China NMPA, AusUDID and others
  • Strategic road map to address UDI system elements across organization, process and technology
  • EU EUDAMED development roadmap for electronic submissions where possible: Vigilance module, other
  • Consultation on responses to health authority or internally identified UDI system issues

Service level options

Basic Service

  • Dedicated UDI Project Lead
  • Up to 25 Hours of Training and Customer Support
  • Up to 25 Hours of Technical Support for API-Integrated Customers
  • UDI Status and Alignment Meetings Provided as an Add-On Service
  • Global Regulatory Advisory and Market Access Support Provided as an Add-On Servicelor sit amet, consectetur adipiscing elit, sed do
Choose Plan

Advanced Service

  • Dedicated UDI Project Lead
  • Up to 50 Hours of Training and Customer Support
  • Up to 50 Hours of Technical Support for API-Integrated Customers
  • Quarterly UDI Status and Alignment Meetings
  • Up to 2 Hours of Global Regulatory Advisory and Market Access Support
Choose Plan

Strategic Service

  • Dedicated UDI Project Lead
  • Up to 100 Hours of Training and Customer Support
  • Up to 100 Hours of Technical Support for API-Integrated Customers
  • Monthly UDI Status and Alignment Meetings
  • Monthly UDI Status and Alignment Meetings

Choose Plan

Additional MedTech Compliance Services

UDI Channel Launch is an optional, one-time cost during the 1st year of channel implementation. Our experts will help with a detailed UDI attribute gap analysis, review of new channel business rules, dedicated support during health authority system integration and provide technical support along with regulatory compliance guidance where needed. 

This is an optional, one-time cost for Life Sciences Solutions subject-matter experts to develop a tailored dashboard analysis of your UDI data. 

We will collaborate closely with your organization to tailor our UDI software to your specific needs, ensuring a fit for your processes and compliance goals. This is an optional, one-time cost for the initial custom feature development and annual maintenance cost.

Yes, our UDI API Integration Services include designing, building and implementing custom middleware tailored to address unique integration needs. We specialize in middleware development and deployment with secure scalable technologies and can deploy within your IT infrastructure or cloud environment for efficient data exchange.

This is an optional, one-time cost for initial development and maintenance.

Yes, we can assist and guide your team through a comprehensive plan to cleanse, transform and repurpose UDI data to meet the requirements of each health authority.

Optional, as requested. 

Our expanded Regulatory Advisory Team can assist you with a wide variety of tasks and topics. Click on the Inquire Now button above or Choose Plan and fill out a few brief comments about your needs in order to facilitate an appointment. We look forward to learning more about how we can assist you.

Talk to a Life Sciences Regulatory Professional Today

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