Written by Katie Gildersleeve, Design Control & Quality Consultant at Enzyme
A traceability analysis is a key aspect of medical device development that helps ensure your final product is safe and effective, addresses your users’ needs, and meets regulatory standards. If not performed correctly or at the right time or frequency, gaps may go unnoticed that could negatively impact patient safety, device effectiveness, overall patient experience, regulatory submissions, and even result in a recall once the device is commercialized.
A traceability analysis involves establishing and documenting the relationships between design inputs, design outputs, and evidence of verification and validation. This information is used to create a traceability matrix, which tracks each requirement through the development process and provides graphical representation of the basic design control relationship as defined by the Code of Federal Regulations (21 CFR 820.30 Quality System Regulation — Design Controls) and International Standards (ISO 13485 Medical Devices — Quality Management Systems — Requirements for Regulatory Purposes). A traceability analysis demonstrates that the device has been developed in accordance with industry standards and best practices. It also helps to identify any potential issues early in the development process so that they can be addressed before the device is released to market.
Unfortunately, some companies view the traceability analysis as a box to check, and they wait until they’re about to commercialize before conducting it. But a traceability analysis is essential to the success of a medical device, as it can improve patient safety, minimize risk, and improve effectiveness. These benefits are not limited to just premarket submissions or a more streamlined regulatory body review; a traceability analysis can also play a role during postmarket surveillance. If there is a device change, having a traceability analysis can help ensure a proper and speedy implementation of the change. If a traceability analysis is left to the end, a company may have gaps in their design control process, like forgotten requirements that didn’t get tested during design verification, or user needs that weren’t validated during a usability study. These gaps could lead to serious setbacks or events all companies want to avoid. Overall, when the traceability analysis is conducted early in design and development and revisited throughout the product development lifecycle, it leads to a more efficient and less expensive product launch.
Ensure full traceability with Enzyme QMS
Your design control structure should be purposefully developed to be similar to the medical device architecture. Enzyme’s design control module supports a hierarchy of design control elements, allowing you to better model design control relationships and subsystems.
More structured design controls also means more complex tracing relationships. Our trace matrix export highlights where traces are missing to help you identify incomplete traceability and where you need to focus next. You can customize these trace matrix exports through custom templates to tailor these exports to your needs. In addition, our design control integration with Jira allows relationships defined within Jira issues to be inherited as relationships within user needs and within requirements.
How to perform a traceability analysis with Enzyme eQMS:
- Step 1: Trace each user need to a design requirement
This defines how the user need has been translated into requirements for the device design and ensures that the design will be acceptable to users and stakeholders.
- Step 2: Trace each user need to a system-level design output
This establishes the specific test article that will be evaluated during design validation.
- Step 3: Trace each user need-design output relationship to validation evidence
This demonstrates how the validation evidence confirms that the design output satisfies the user need.
- Step 4: Trace each requirement to a user need
This defines how the requirement is necessary for stakeholder or user acceptability. Fulfillment of the corresponding requirements implies fulfillment of the user need.
- Step 5: Trace each requirement to a design output
This defines how the requirement has been implemented into the device design and establishes the specific test article that will be tested during design verification.
- Step 6: Trace each requirement-design output relationship to verification evidence
This defines how the verification evidence confirms that the design output satisfies the requirement, or in other words, that the design outputs meet the design inputs. Fulfillment of the design outputs implies fulfillment of the requirements.
- Step 7: Trace each design output to a requirement
This demonstrates how design outputs have been established to fulfill the device design requirements.