If it isn’t documented, then it didn’t happen. Meeting traceability requirements for your medical deviceĭocumentation is the cornerstone of traceability. You don’t want to find yourself in a position where you’re needing to manually reconstruct something that should have been done months earlier. This often happens when teams wait until the last minute to create their traceability matrix. It’s relatively easy for mistakes or oversights to happen. Secondly, as with most manual systems, this approach is prone to error. This takes a lot of time and effort and can quickly become unwieldy as the design of your device grows. Validation may include clinical or simulated performance evaluations, which is why it is important to use terms in your User Needs that are not too ambiguous.Ī traceability matrix can be created using Excel or some other spreadsheet tool however, this method can present several challenges.įirst (and probably the most obvious), it’s a manual system meaning that all information has to be keyed. This closes the loop and shows how your design has fulfilled the original User Need. This could be shown in the form of released drawings that show the geometry and tolerances of the device, or through testing.ĭefine how you will validate that your design has met the User Need. For example, if the Design Input requirement states that a device must be a certain size, this may be included in a drawing which would become one of the Design Outputs.ĭefine how you will verify that your design has met the specification. Design Outputs show that you have incorporated the Design Inputs into your design. For example, “The device must be X lbs +/- Y lbs.” There may be other Design Inputs that come out of a User Need asking for a device to be “portable” as well, such as battery-operated power, or geometry requirements.ĭefine Design Outputs that meet your Design Inputs. Instead of using ambiguous terms such as “lightweight,” or “small,” Design Inputs should be both measurable and attainable. Translate your User Needs into Design Inputs. “Why did we add this feature? Because the user needs the device to do X.” For example, “The user needs a device that is portable.” Ideally, these User Needs will come from actual users. How do you create a traceability matrix? There are a few key steps required:ĭefine your goals in the form of User Needs. This bird’s eye view of your design process allows your team to manage projects more effectively than ever before. It can help you trace and define complex needs and expected outcomes. When done effectively, a traceability matrix will allow a medical device manufacturer to see a clear path between the resulting physical product and the design history, including evidence of quality controls and that the goals you have set have been met.Ī traceability matrix is also an excellent internal tool for project management purposes. The underlying importance of the traceability matrix is that it helps to ensure your team can gain quick insights into relationships in your design as well as ensure everything is accounted for and nothing is missed during the Design Control process.įor example, a traceability matrix can help you quickly determine how a particular design input relates to user needs, how a design change can impact your design validation process, and how any change can impact your testing and verification processes. What is a traceability matrix?Ī traceability matrix is a visual representation of the relationships and linkages between key areas of your design process, for example, your User Needs, Design Inputs, Design Outputs, Design Verification, and Design Validation. Here’s what you need to know about what a traceability matrix is and how to create one.įREE RESOURCE: Click here to download a PDF of 5 steps you can follow to create a traceability matrix for your medical device. The ability to demonstrate traceability also plays a very important role in the submission of your device. E) the methods to ensure traceability of design and development outputs to design and development inputs.
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