How to stay on top of your product development and easily organize your FDA and CE submission
If you have any software on your device, and who doesn’t these days, Traceability Matrix (TM) is one of your best friends.
Traceability is required by regulations.
For FDA, 510(k), DeNovo, or PMA, traceability is required as part of your Design History File (DHF). Soup to nuts, they expect you to demonstrate how everything is connected, where and how the requirements are met.
For the CE mark, the requirements are similar, if not the same!
Failure to ensure complete documentation traceability is one of the FDA’s top 5 violations.
A non-compliant FDA or CE audit is expensive no matter who you are… small or large, but especially if you are a startup.
“Insufficient documentation of design input requirements as required by 21 CFR 820.30(c) . . . your firm has not defined and documented clear, appropriate design input requirements . . .”
Another costly mistake is to assume that an FDA inspector will review only the most recent design history files and not the entire history, documented history. You need to document everything, from the beginning to the end of the project. Each document should show details, approval history, revisions…
“Unable to create a design history file as required by 21 CFR 820.30… your firm does not have a design history file (DHF) for the device prior to this device release and there is only one (1) publication of a DHF record . “
So how do we avoid disaster?
A tracking matrix can be very difficult to create, it can take months to compile by hand, especially without the right tool. Creating and maintaining a TM can be time consuming and difficult, not to mention all those messy spreadsheets and ongoing update issues! And be real, no one will help you!
With the right tool, TM can significantly reduce your project risk and set the stage for your product lifecycle – not to mention make your job easier and put you in control of your project.
Use QMS software with an integrated tracking matrix that allows you to build a matrix for all your medical device regulatory needs. This will be the cornerstone of the DHF or CE technical file.
Each entry should be organized and should show the details, revisions, history and marked links from the beginning of the project.
What you need is a tracking matrix that is fully integrated into project and quality management.
You’ll never start another device project without it again. This will make your regulatory life a lot easier.
Prove your claim that you follow recognized industry validation practices with the Traceability Matrix.
Build your tracking 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 the project was developed in accordance with an approved project plan and the requirements of 21CFR 820
Ensure requirements and documentation are completed and completed. With the Traceability Matrix, you will be able to look far back, to the very beginning of the project and be sure and confident that you have met all the requirements.
Don’t underestimate the power of the Traceability Matrix, if it becomes part of your and your team’s daily work, it will surely be one of your most loyal tools in the FDA clearance process.
Comply with the regulations, not because it’s mandated by the FDA, but because it makes good business sense and helps keep you from going crazy!
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