Traceability for medical devices

Insight in Brief

The article elaborates on traceability requirements in the medical device development process.

Briefly, the traceability must be ensured between:

Product requirements and tests
measurement results and national standards
medical devices and their components, from manufacturers to the end customers

Introduction

If you are working in the medical device industry, you will hear the term “traceability” very often. This article provides an overview of three main traceability types that need to be established during the development of the medical device:

Traceability between product requirements and tests
Traceability between test measurement results and national standards
Traceability between devices and their components from manufacturers to the end customers

These traceability types can be designed using different tools. Professional requirement engineering tools can generate automatic traceability reports. While Word and Excel sheets may also be used to prove traceability, the probability of a human error is quite large.

Traceability between product requirements and tests

It is one strategy to start implementing a device when you have an idea in your mind, but would it not be better to start with the end user’s needs? Starting with the user needs, we collect the user requirement specification (URS) and derive from there the functional requirements specification for the product (FRS). In parallel, the risk management process creates risk control measures also resulting in functional requirements. All these requirements then must be implemented in subsystems – mechanics, electronics, software, and so on. The requirements must not only be implemented but also tested with corresponding traceability to be established. The following graphic shows the traceability with arrows in a simplified V-Model process:

The easiest way to show traceability, is to create one or multiple matrices, showing the traceability as visualized above. Such a matrix for risk management could look like this:

In this example, the risk control measure [RCM 01] is implemented in the functional requirements [FR-01] and [FR-02]. The functional requirement [FR-01] is then verified in test [V-01].

The traceability matrix allows the technical file reviewer to quickly check, whether all risk control measures have their implementation and verification tests performed.

Two of the tools we use at IMT to implement this traceability in an automatic way are:

Traceability between test measurement results and national standards

During verification, something usually must be measured: a time, a distance, a voltage, or the gas flow. To measure a distance, for sure, I can use the ruler I have on my desk, but are the 25mm, I’m measuring – really 25mm? How can I ensure that? The testing equipment must be calibrated, which provides you with reference value and measurement uncertainty.

This calibration can be done in your own calibration lab or in an external calibration lab (for example at the testing equipment’s manufacturer). If you calibrate your equipment in your own calibration lab, you need to have your references calibrated too, and the calibration of these references again and so on. This chain should go back to the calibration to the national standards and it should be possible at any time to get this chain reconstructed. This is where the traceability between test results and national standards comes into play.

One way to ensure this traceability is to use calibration services from an accredited calibration lab which is regularly inspected by the accreditation body. See another article on the content of calibration certificates, which might be of interest.

Traceability between devices and their components from manufacturers to the end customers

The third traceability type that is mandatory to be established for medical devices is the traceability between devices and their components from manufacturers to the end-customers. The target is, that the manufacturer can recall a device after the shipment if the failures are detected at the end-customer. To reduce the scope of the recall, also the different (critical) components, that have been used to build up a device, should be known. In case a supplier detects an error, the manufacturer can recall only the affected series of medical devices and does not have to recall the whole production lot.

Most ERP systems provide the option to establish this type of traceability, but also a SharePoint list could do this work. Do you have additional questions about traceability? Then please get in touch with our Regulatory and Quality Service team at IMT.

Summary

As a medical device manufacturer, you need to ensure that your requirements specification (from top to bottom) and your tests are traceable; there is evidence that every requirement is tested and the rationale for every requirement why it is implemented. When testing, your measurement results must be traceable to national standards and you need to trace, which component has been sold in which device to which customer to ensure you are able to perform field actions if required.

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