With UDI regulation compliance dates already established or in sight, medical device manufacturers have to prepare and meet specific device coding and labeling requirements for their products – and it’s not just for device labels and packaging anymore.  This is where direct part marking (DPM) comes into play. When implementing DPM identification, the need to control the mark quality ─ and process ─ becomes increasingly important. This is why Optel offers the UDI-compliant MarkSure™ solution component, featuring basic DPM inspection and verification, up to the optional grading, as well as serialization and full aggregation capabilities.              

With DPM verification systems, the goal is to confirm that the marked 2D Data Matrix or human-readable characters meet an acceptable level of quality, as defined by specific industry standards. Our advanced vision and software technologies offer an industry-leading tool to guarantee the accuracy and reliability of the information generated by your packaging process.  

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Take a look at the MarkSure data sheet.

Be on the mark and make the grade in UDI.

MarkSure™ is a UDI-compliant vision solution for medical device manufacturers requiring DPM inspection and verification of medical devices such as implantables and other reusable medical devices.

The MarkSure™ solution can be tailored to your needs, based on your manufacturing workflow ─ from manual to fully automated ─ and your degree of IT integration (ERP/MES).

Key Attributes

Medical device DPM inspection and verification

  • Inspection and verification of human-readable code 
  • Inspection, verification and grading of 1D and 2D codes according to ISO/IEC standards

Optical character recognition and verification (OCR/OCV)

Ready for Track & Trace ─ serialization and aggregation


  1. Robust optical character recognition and verification (OCR/OCV)
  2. Accurate reading and grading of 1D, 2D and linear codes, according to ISO/IEC standards
  3. Complies with FDA 21 CFR Part 11/audit trail
  4. I/O control – stand-alone units (no PLC integration required)
  5. Automated QA control
  6. UDI data and aggregation* management
  7. Connectivity to industry-leading ERP/MES systems, batch record and device control


  1. Ensures accurate product identification and traceability
  2. Ensures that barcodes meet the required quality threshold
  3. Mitigates human error
  4. Complies with regulated and quality-controlled processes, for seamless integration
  5. Configurable, scalable and future-proof solution
  6. Easy data management and handling to comply with specific regulations

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Solutions tailored to your needs

Line Elements

Line elements such as cameras, scanners, printers, handheld devices, human-machine interfaces (HMIs), light stacks, etc. represent an important part of the final solution. Optel partners with the best OEMs to provide you with top-of-the-line components. We focus on our core expertise to create efficient state-of-the-art solutions with our superior vision technology, integrating it seamlessly with the adequate line elements.

Level of IT integration

All MarkSure™, PrintSure™ and PackSure™ solutions are offered with Optel's proprietary software to accommodate your level of IT integration ─ from no connection to full connectivity to ERP/MES for verification and reconciliation. According to the level of connectivity you need, you can choose from the OMProdigy™, OMVirtuoso™, or OMMaestro™.

Line Equipment

All MarkSure™, PrintSure™ and PackSure™ solutions can be combined with Optel's optional line equipment to accommodate your packaging process needs.


RFID Tracking throughout the Packaging Process and Beyond!

Adding RFID tags to your medical devices or their packages creates ultimate value, as it enables you to manage your entire product life cycle. Not only does it help track the products throughout their packaging workflow, it can also help downstream, in warehouse inventory management, up to the end-users’ stock and consignment areas, within their premises. Through RFID tracking, all this data, including UDI, is easily accessible and can serve a multitude of useful purposes throughout the value chain. Optel has worked on numerous RFID projects for customers wishing to implement comprehensive RFID solutions. Let us know what your particular needs are ─ we are sure to put together an ideal solution, just for you!

Discuss your project with our experts.