1. Incoming Inspection

At this critical initial stage, the MediTrace software plays an essential role in ensuring the integrity of raw materials, outsourced processes, and processing aids. As these materials and services arrive, they are thoroughly inspected to confirm compliance with quality standards.

Each item is immediately logged into MediTrace, linked to its supplier’s lot number, and paired with a digitally uploaded Certificate of Conformity (CoC). This meticulous documentation process guarantees traceability and establishes a solid foundation for quality assurance right from the start.

2. Subparts and materials Stock

Besides the management of your resources, MediTrace allows you to manage the stock of your purchased or produced subparts.

The system is easily searchable so you can find the right parts of raw materials in an instant, so you can check if the materials are readily available for production without unnecessary surplus or shortages. In case any subparts are low on stock, you can easily plan it in the production planning.

3. Production Planning

MediTrace allows companies to manage production planning, enabling a streamlined and responsive manufacturing workflow.

The software allows for real-time adjustments and prioritization of certain production efforts that are needed, ensuring efficient use of resources and timely execution of manufacturing processes. This dynamic approach helps manufacturers maintain agility and responsiveness in their production operations.

4. Production Tracking

During production, MediTrace tracks each step of the manufacturing process with precision. Each batch is assigned a unique identifier and monitored through QR-code scanning, ensuring that every phase of production is documented.

Operators can scan the QR-code of the batch, and then they can scan the production step that they are executing. This allows for real-time registration of production activities in a highly efficient manner. This comprehensive tracking system includes handling non-conformities and maintaining rigorous QA control over devices, production flows, production steps, measurement equipment, user activities, and statistical analysis.

Such detailed oversight helps in identifying and addressing issues promptly, enhancing the overall quality and efficiency of production.

5. Digital Batch Records

The digital batch record feature in MediTrace captures all critical data throughout the manufacturing process. It records every production step, inspection values (AQL), and links technical drawings, ensuring a comprehensive documentation trail.

Each batch record undergoes digital approval by QA before release, and a PDF report can be generated for record-keeping and compliance verification. Additionally, MediTrace supports QA in planning the calibration of measurement equipment, maintenance of production machinery, and tracking the expiry of processing aids, ensuring that all equipment and materials are in optimal condition and compliance.

Through these enhanced functionalities, MediTrace ensures that every aspect of the production process is monitored, documented, and managed efficiently, supporting medical device manufacturers in meeting stringent regulatory standards and maintaining high-quality production outcomes.

Conclusion

MediTrace software stands at the confluence of numerous critical aspects of the medical device production process. This comprehensive system ties together an extensive array of elements that underpin the manufacturing ecosystem:

Management of production resources

Manage your raw materials, processing aids, manufacturing equipment as well as monitoring and measuring equipment.

‍Registration of production activities

MediTrace allows the registration of production activities to be highly efficient and impossible to manipulate. This makes sure that as a company you will be saving time and money, while increasing your compliance.

Master Device History record management

The system is made scalable in the sense that the quality team can create production steps, make production flows out of these steps, and subsequently link these production flows to their master devices. When there is a change in a production step or flow, MediTrace automatically generates new master devices history records and archives the older one.

Quality Control

The software is meticulous in recording discrepancies, capturing every defect, deviation, and nonconformance. It acts as a guardian that safeguards the integrity of the production process. It allows for measurements that are needed during the production process, such as in process controls or final inspections.

Data Integrity and multi dimensional Traceability

MediTrace ensures that every piece of data, along with its historical trail, is verifiable and aligns with the established procedures, enhancing transparency and trust. Explore traceability not only on batch record level, but also on the level of raw materials, subparts, and equipment.

In weaving together these threads, MediTrace provides a complete solution, with both attention for the production operators as well as the quality team. It is easily configurable for the quality team, while registering the production activities as an operator becomes very simple.

This results in high efficiency and full compliance on the level of production. This cohesive approach transforms quality assurance from a concept into a tangible reality, providing a framework that not only meets but exceeds the standards of modern medical device manufacturing.

Optimize medical device traceability with electronic batch records