Our consultants are passionate advocates for customers, enabling the rapid deployment of mission-critical applications,
sharing industry knowledge, and implementing cost effective and efficient solutions.


SteriTrack’s UDI Solution Architecture provides a comprehensive solution to support your
unique device identification (UDI) compliance efforts from beginning to end. SteriTrack encourages customer feedback and accelerates skill acquisition among team members to ensure your project’s success. We ensure your FDA and EU MDR medical device project includes a fully compliant UDI component through the following strategies:

Deep analysis to identify and address gaps in UDI readiness 

  • Comprehensive present “as-is” UDI readiness assessment

Ensuring proper UDI data formatting 

  • Guidance on the best labeling standard (GS1, HIBCC, ISBT 128) for each organization

Computer systems validation/verification and soware analysis

  • Ensure UDI labels and direct part marks are scannable by customers
  • Guidance on supply chain management and validation to support UDI implementation

Business Analysis

Quality Assurance

  • Assisting you to incorporate UDI processes into your quality management system and production operations.

Regulatory Affairs

  • Assurance that device track and trace requirements are met

Mandatory Reporting and Compliance

  • Customizable process control metric (PCM) reports

Vendor/Software selection and Data Management

Collaborative Project Planning

  • Accurate UDI product/project cost estimation using our proprietary systems Guidance on needed size and scope of effort
  • Clear and cost-effective design of future “to-be” UDI project plans
  • Focus of project effort into specific tracks with defined deliverables
  • Work Breakdown Structure to drive project threads
  • Responsibility Matrices to keep each resource focused on deliverables
  • Flexible approach to ensure that issues, risks, and assumptions are managed
  • Comprehensive validation solutions
  • Driving focus on UDI readiness within agreed budget


SteriTrack’s expert team has vast knowledge in the area of web technology and medicl device unique device identification (UDI) requirements. They have been working with regulatory agencies, such as the FDA, standard setting bodies, such as ISO, and medical device companies for almost a decade now. SteriTrack can assist you to:

  • Overview of regulatory requirements for UDI in the U.S. and EU
  • What products require UDI and the timeline for implementation
  • Review of the U.S. FDA Quality System Reg ulations (QSR), i.e. 21 CFR 801, 820, 830
  • Information required for the UDI
  • Guidance on choosing an Issuing Agency for UDI labeling
  • Product labeling and packaging requirements
  • Compliance with the latest industry standards (ISO, AIM, GS1, HIBCC)
  • UDI training and project management
  • Work with staff to execute a project schedule and minimize the impact to your
  • Resources
  • And many other services.


The team at SteriTrack is here to solve your UDI and surgical inventory documentation challenges, reach out today.