What is a trial master file?
If you’re a medical device manufacturer, chances are, you’ll need to conduct one or more clinical trials before you can prepare your product to go to market. It’s not just the trial itself that matters, though—the way you record how everything unfolds is equally as important, not only for your own peace of mind but also because it’s essential to ensure you’re adhering to all relevant guidelines. That’s where trial master files come in.
In this article, we’ll go over what a trial master file is in relation to ISO 14155, what needs to be included in one, the benefits of creating one, and how to go about it. Let’s delve straight into it.