Medical Device Technical Files

Posted by Maven Profcon Services LLP on August 10th, 2022

A medical device technical file contains all the information that a manufacturer needs to produce a product. It includes details about the product itself, its components, how it works, and any special instructions for use.

What Is a Medical Device Technical File?
A medical device technical filing (MDT) is a document that provides information about a medical device. MDTs are used by manufacturers to provide detailed information about the products they sell. They contain all the information that a company needs to produce a product, including details about the product itself; its components; how it works; and any special instructions for using the product.

Why Do Manufacturers Create These Files?
MDTs are required by law in some countries, such as the United States. In other countries, they are voluntary. Companies use them to help ensure that their products meet safety standards and comply with regulations.

How Do They Work?

These files contain information on how the product works, what its specifications are, and any other relevant details.

What Should You Include In Your Files?
There are several different types of technical files available for use by medical device companies. They range from simple PDF documents to complex Excel spreadsheets. Each type has its own advantages and disadvantages.