Every aspect of the medical device life cycle — from concept to post-market activities — is subject to traceability as required by the U.S. FDA and ISO. Providing these regulatory authorities with documentation demonstrating an interrelated medical device development process and alignment with design controls is imperative.

Creating a design control traceability matrix is the solution many manufacturers use to ensure regulatory compliance in medical devices.

What’s a design control traceability matrix?

Part of a product’s design history file (DHF), a traceability matrix provides a view of how medical device design control requirements are satisfied, and how they interconnect with device specifications. The matrix is intended to show a clear reverse path from the manufactured device to design history, quality controls, and the initial goals of the medical device development process.

There are various ways the matrix can be structured or laid out, and the FDA is not specific on requiring a matrix, as long as traceability can be shown. Nowadays, however, electronic Quality Management System (eQMS) softwares can aid product development teams in creating an easy to use, visually impactful, and effective traceability matrices.

All steps need to be documented to meet compliance requirements. Maintaining a traceability matrix from project outset through completion systematically captures the information necessary to prove device safety and effectiveness. Likewise, it shows that all testing and risk mitigation meets design control traceability best practices as outlined in ISO 13485, §7.1 and §7.3.2.

Keeping teams and projects on track

There is no one way to visually format a traceability matrix. Spreadsheet programs are popular foundations for matrix templates, which are widely available on the internet. As previously mentioned, eQMS solutions also provide effective frameworks for a traceability matrix. Whichever tool is chosen is secondary to how the matrix template helps your team meet medical device design control requirements by:

  • Initiating design controls at the beginning of device design and development for optimal traceability
  • Working cross-functionally to maximize efficiencies and collective team input
  • Defining owners of specific design control activities (e.g., product specifications, verification processes, etc.)
  • Routinely touching base on the status of the project, activities, and requirements

Creating a traceability matrix must be deliberate to minimize human error and ensure that medical devices are of the intended use, safety, and quality throughout product development. Use these five steps as a guide to build an effective matrix:

  1. Identify user needs to define device goals. Get to the why behind the design steps by asking questions about the necessity of features. Having no user need attached to a design feature warrants further investigation before moving forward.
  2. Define design inputs. Design inputs directly correlate to user needs, and should be defined with measurable and attainable specificity.
  3. Define design outputs. Design outputs demonstrate that design inputs exist within the device design. For example, if a design input requires that the device has a specially positioned handle, a schematic showing the handle placement would be a design output.
  4. Implement verification and validation. Define the data necessary to verify the design meets specifications (test results, drawings, etc.) and to validate the design meets the original project goals and user needs (inspections, performance evaluations, etc.) and compliance requirements. Document the information and iterative results in the matrix.
  5. Review and audit the traceability matrix. Periodically have the internal team evaluate the traceability matrix to make sure the design is on track and all requirements are being met. This task is valuable for assessing internal progress, and ensuring information is up to date for any regulatory audits.

Additionally, integrating proper risk planning, analysis, and management throughout the development process in your design controls is imperative to ensuring completeness. Residual risk that is identified during risk assessment should be properly mitigated and controlled within the design control process.

Using these steps to create a design control traceability matrix is essential to help clarify and document the medical device development process. However, working with an experienced medical device consultant amplifies the benefits.

Leverage the insights and experience of a medical device consultant

A medical device consultant brings experience and objectivity to traceability matrix creation and implementation. Collaborating with a consultant partner gives manufacturers opportunities to ask questions, seek feedback on device goals, user need, and other design controls, and get practical guidance about matrix formatting and structure to fit regulatory expectations.

Having a medical device consultant such as Kapstone Medical come alongside internal teams paves the way for a successful medical device development process. What’s more, involving a consultant at the outset gives them deeper insights into device purpose, functionality, and desired outcomes — all of which makes it easier to navigate regulatory compliance and device clearance activities.

Learn the strategies and actionable steps necessary to go from medical device concept to US FDA clearance with the help of a trusted medical device consultant partner in our guide, US FDA 510(k): from Concept to Clearance. Click below to download your copy.

Interested in starting a project with Kapstone Medical? Get in touch today!

Get in Touch