Traceability is at the heart of the product development process and is mandated by the medical device standards and guidelines. As traceability is central to the development of safe medical devices and essential for regulatory compliance, it must be implemented in the most effective way.

What is an effective traceability method?

• Effective traceability helps you document the life of the product development process so that every input/ output can be easily traced all the way back to the source of the initial requirement.

• Effective traceability should be synchronized with your QMS system

• Effective traceability should be flexible enough to respond to changes

• Effective traceability should show clear linkages back through to the original requirements – including risks – through the different stages of the product development and lifecycle.

• Effective traceability should demonstrate that the design was developed in accordance with an approved design plan and the requirements of 21CFR 820

• Effective traceability should be integrated with Risk controls and Risk assessment. Hazards have to be traceable back to the risk analysis, risk evaluation, and the implementation and verification of the risk control measures.

• Audit trail

But the implementation of effective traceability can be time-consuming and complex, especially if documenting and managing requirements and changes are dealt with using a traditional, a.k.a. manual, system.

Why is an effective traceability method important?

A traceability matrix is required by both FDA and CE mark. It’s important because it has been proven to increase safety and reduce defects in medical device development and keep the development process on the right track. Effective traceability helps companies reduce the risk of missed requirements, and ensures 100% test coverage, and that it is documented.

Why is so hard to implement an effective traceability method?

While the standards and guidelines mandate traceability, there is diversity in the level of traceability that is required and a lack of detailed guidance on how to best implement an effective and compliant traceability matrix.  

How do achieve and implement an effective traceability method?

Implementing an effective traceability process can be difficult, time-consuming, and messy. 

An ideal solution is to implement a Traceability Matrix that is designed specifically to meet the FDA’s and CE Mark regulatory and compliance requirements for Traceability.

It should also be flexible, adaptable, and customizable to meet individual medical device projects. 

It should also be integrated into your company's QMS, so every input can be organized cross-reference to Project Tasks, Design Input changes and revisions, Approvals, testing, verification, and validation testing, and this right from the very beginning of the product development stage. 

A strong traceability matrix solution must be able to capture information that needs to be traced at different points in the process, share the information with the right people at the right time, and generate useful reports.

Although Excel can be useful, there is one such ideal solution that you should consider. It will help with product development, save time, foster innovation, improve quality, and reduce development process costs.