If you have any software in your device, and these days who doesn’t, a Traceability Matrix (TM) is one of your best friends.
Traceability is required by regulations.
For FDA, 510(k), DeNovo or PMA, a traceability is required as part of your Design History File (DHF). Soup to nuts, they expect you to demonstrate how it is all connected, where and how requirements were met.
For the CE mark, the requirements are similar, if not the same!
Failure to provide full traceability of documentation is one of the FDA’s top 5 violations.
A non-compliant FDA or CE audit is costly, no matter who you are… small or big, but especially if you’re a startup.
“Failure to adequately document design input requirements as required by 21 CFR 820.30(c)… your firm did not define and document clear, appropriate design input requirements… “
Another costly mistake is to assume that an FDA inspector will review only the recent design history files and not the whole history, documented history. You need to document everything, from the beginning to the end of the project. Every document needs to show the details, approval history, revisions…
“Failure to establish a design history file, as required by 21 CFR 820.30… your firm has no design history file (DHF) for the device prior to this version of the device and there is only one (1) DHF record post.”
So, how to avoid disaster?
Traceability Matrix can be very difficult to create, it can take months to put together manually, especially without a proper tool. Creating and maintaining a TM can be time-consuming and difficult not to mention all those messy spreadsheets and ongoing updating struggles! And be real, nobody is going to help you!
With the right tool, a TM can significantly reduce your project risk and set the foundation of your product lifecycle – not to mention make your job easier and put you in control of your project.
Use QMS Software with integrated Traceability Matrix that lets you build a matrix for all your medical device regulatory needs. It will be the cornerstone of the DHF or CE Technical File.
Every input should be organized and should show the details, revisions, history and mapped out relations, from the very beginning of the project.
What you need is a traceability matrix that fully integrated into the project and quality management.
You’ll never start another device project without it again. It will make your regulatory life a lot easier.
Prove your claim that you follow recognized industry practices for validation, with Traceability Matrix.
Build your Traceability Matrix as you develop your product… on the go.
Adequate record keeping is one of the most important parts of regulatory compliance. So organize it!
Demonstrate that design was developed in accordance with an approved design plan and the requirements of 21CFR 820
Ensure requirements and documentation are completed and implemented. With Traceability Matrix, you will be able to look way back, at the very beginning of the project and to be sure and confident that you delivered all the requirements.
Do not underestimate the power of Traceability Matrix, if it becomes part of your and your team everyday work, it will for sure be one of your most loyal tools in the process of getting FDA clearance.
Be compliant with the regulations, not because it is FDA mandated, but because it makes good business sense, and helps you from going crazy!
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