Managing quality throughout the supply chain with UDI.

Be prepared for UDI requirements with USDM’s implementation and compliance solutions and expert guidance on global regulations.

USDM Life Sciences is the industry leader in Unique Device Identification (UDI) regulatory compliance solutions for the medical device industry. With well-established relationships with the most prominent IT vendors in the world, and an experienced team of subject matter experts led by Jay Crowley (who developed the framework and authored key requirements for the FDA’s UDI system), we can help your organization execute a program to support your UDI efforts.

Tailored to the UDI Final Rule in the United States and the UDI Regulation in the European Union (EU), our UDI guidance and implementation solutions can help you utilize the benefits of UDI while achieving regulatory compliance.

We offer our customers the following UDI Guidance and Services: 

Global Readiness Services 

  • UDI Audits 
  • UDI Program Design and Execution 
  • UDI Product Analysis (class III, FDASIA, II, I) 
  • UDI Business Process Analysis and Improvement  
  • UDI Policy Development 
  • UDI Regulatory Guidance 

Global Regulatory Database* Submission Services and Support 

  • Submission Strategy 
  • Submission Preparation 
  • Submission Support  
  • UDI System Enhancements and Validation 

Region-specific Services 

Education and Training 

  • UDI Regulation Overview (e.g. US FDA UDI Final Rule, MDR/IVDR) 
  • UDI Regulatory Database* Training 
Thought Leaders

Leading experts in every Life Sciences field.

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Bob Lucchesi

Vice President of Global Regulatory Compliance, Quality Assurance and Auditing

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