PROFESSIONAL SERVICES

STERITRACK’S PROFESSIONAL SERVICES

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.

DIRECT PART MARKING SOLUTION

SteriTrack’s Direct Part Marking Solution provides an inclusive solution to support your unique device identification (UDI) compliance efforts. Whether you need direct part marking validation or verification with process control metric (PCM) reports for medical devices and surgical instruments, we are here to assist you. We ensure your FDA and EU MDR medical device project includes a fully compliant UDI component through the following strategies:

Ensuring proper UDI data formatting 

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

Computer systems validation/verification and software analysis 

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

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

LET’S WORK TOGETHER

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