Developing a Med Device Traceability Matrix

by | Apr 30, 2021 | FDA, ISO, Medical Devices, Testing

If you have developed a medical device, you know how important the concept of traceability is. Every facet of the medical device lifecycle requires traceability, from concept development, to manufacturing, to post-market. There are so many regulatory processes in place to ensure traceability by design that sometimes the simple methods can be overlooked. Every medical device that I have helped develop has utilized a robust traceability matrix. A traceability matrix is a simple visualization of the linkages between the key areas of design controls, such as design inputs, design outputs, and V&V activities.

Although not specifically required by any regulatory requirement or international standard, developing a traceability matrix is industry best practice and heavily recommended by both the FDA and ISO 13485:2016. In fact, both the “Planning of Product Realization” and “Design and Development Planning” clauses of ISO 13485:2016 talk about traceability activities and methods to ensure traceability.1

So, where to begin? The obvious starting point is defining User Needs. Next, you should translate your user needs into design inputs, then define design outputs, and finally trace to your verification and validation activities. This flow can be achieved in any number of ways, like using Excel or any other spreadsheet software. Visualizing the design and development process by showing the translation between columns can be an easy way to demonstrate traceability. This also creates one key location for all your pertinent design & development information.

Creating a traceability matrix for your medical device also ensures sustainability in your design controls process. By creating one simple visualization of how your product was developed, you create a “roadmap” for any team members that will come after you. This roadmap is what any regulatory inspector will want to see, so creating a robust traceability matrix can hold many purposes.

EMMA International has helped develop traceability matrices for several medical devices, whether it was creating one as part of a new product realization, or reverse-engineering one through a remediation effort. If you’re unsure where to start, or need help developing a robust trace matrix, our technical team is here to help! Give us a call at 248-987-4497 or email info@emmainternational.com to find out more.


1International Organization for Standardization (Feb 2016) ISO 13485:2016 Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes retrieved on 04/24/2021 from: https://www.iso.org/standard/59752.html

Madison Green

Madison Green

Director of Technical Operations - Mrs. Green serves as EMMA International’s Director of Technical Operations. She has experience in technical writing, nonconforming product management, issue evaluations, and implementing corrective and preventative actions in the pharmaceuticals and medical device industries. She has experience cross-functionally between R&D, lean manufacturing operations, and RA compliance. Mrs. Green also has academic and work experience with human health-risk engineering controls, physiological biophysics, and clinical research. Mrs. Green holds a Bachelor of Science in Biosystems Engineering with a concentration in Biomedical Engineering from Michigan State University. She is also a Certified Quality Auditor (CQA), and is currently pursuing her M.S. in Quality Management.

More Resources

Process Validation

Process Validation

All right, you have just gotten all of your paperwork together, submitted the right forms to the right people, set up your factory, hired and trained your staff; now it’s time to make the medical devices. The regulatory nonsense is over and done, right?
The Role of Management in Product Quality

The Role of Management in Product Quality

Depending on the factory, some production employees may find it surprising that management has an important role to play in a quality system.  21 CFR 820.20 mandates that “Management with executive responsibility shall establish objectives for, and commitment to, quality”.[1]  The Federal Government expects that management takes an active interest in improving the output of their company, at least in the case of medical device manufacturers.
Corrective and Preventive Action

Corrective and Preventive Action

In addition to helping manufacturers make better products, corrective and preventive actions are important because the process is legally required by the FDA when making medical devices for the US market.

Ready to learn more about working with us?

Pin It on Pinterest

Share This