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 firstname.lastname@example.org 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