Laser Marking + ERP = Complete Solution

The medical device tracing system combines laser marking technology with an ERP system to enable full data tracking from production to distribution.It explains how to use laser marking technology to mark unique identifiers (UDI) and how to integrate production, inventory, and post-sales data into an ERP system. This helps businesses meet compliance requirements, improve management efficiency, and reduce risk.

Why do medical device manufacturers need a tracking system?

The medical device industry requires the highest levels of safety and compliance, and if problems arise, the ability to quickly locate problematic batches and recall products is a "lifeline" for the enterprise.Traditional manual recording is inefficient and prone to error, but laser marking technology coupled with an ERP system enables precise management of "one item, one code," with data being updated in real time, and greatly reducing the risk of human error.

How does the laser marking technique achieve precise marking?

Laser etching is the first step in medical device tracking.Its advantages are:

The new process has the advantages of permanence and high precision.

The laser directly etches a UDI code, production date, and other information onto the surface of the device, which is resistant to wear and hard to alter, and meets the requirements of the FDA and other international regulators.

It can be adapted to suit different materials.

Whether the object being marked is a metal surgical instrument or disposable plastic, the laser parameters can be adjusted to ensure that the markings are legible, thereby avoiding the problem of missing or illegible marks due to material differences.

How does an ERP system coordinate data from all stages of the production process?

The labels are not enough, however, because the ERP system is the "brain" of the traceability system.Key functions include:

Production data is automatically related.

After the production line scans the UDI code, the ERP system automatically records the batch number, operator, and quality inspection results, thus avoiding the delays and errors that can occur with manual data entry.

The inventory and flow of goods are transparent.

By scanning the codes at the time of entry and exit, the inventory status is updated. The data of the distributor and the end-user hospital are synchronized. If a problem is discovered, the affected range can be identified in 30 minutes.

Three practical suggestions for implementation.

Choose hardware that is compatible with many different systems.

The laser marking equipment needs to support an API connection to the ERP system, to avoid creating "data islands.It is best to choose a firm that offers customized development services.

The system will be put into operation in stages.

The company first tested the system on a small number of products to confirm that the barcodes were clearly visible and could be scanned with high accuracy.

Preparation and contingency planning.

Production line employees must be able to handle basic troubleshooting, such as applying a replacement label when the original is smudged. At the same time, the ERP system has an automatic alert function that notifies staff when data anomalies are detected.

This is the real value of the experience.

After one orthopedic equipment manufacturer began using the system, its average recall response time dropped from five days to four hours, and its annual quality assurance costs fell 18 %.Even more important, customer complaints about product quality have been reduced by 62 %, which has directly increased the company's competitiveness when bidding for contracts.