Design History File vs. 510(k) vs. Technical File

Design History File vs. 510(k) vs. Technical File

The healthcare industry also called the medical industry is the scope of organizations and non-benefit organizations that give medicinal services, medical device manufacturer etc. The healthcare industry is going through a transformation, and to achieve success in this growing competitive environment, organizations need to make notable investments in processes and technologies to improve medical care.  It involves the generation and introduction of products and services lending themselves to keeping up and restoring health.

Design History File (DHF)

The design history file is documentation that mentions the process of a new device with its finished device design history. The design history file is an FDA term described in 21 CFR Part 820.30, which discusses design controls and how they should be kept in a design history file (DHF). This is basically the gathering of records from the design and development process.

The 510(k) Submission

There are a lot many companies which couldn’t provide good reports of their company’s established design controls and also design history file.  This ought to be your initial step before starting with your 510(k) as this process provides documentation report in the form of evidence of your finished product/device which actually proves that your device is safe for the patients and is effective and powerful too.

The Technical File

A technical file is considerably likewise to a 510(k) than a design history file. This technical file is a collection of information in the form of documents that consists of details about the product and also that the product was designed as per the requirements of the Quality Management System (QMS). Every finished product/device that has a CE mark, it is compulsory for that product to have a technical file which consists of data that gives evidence about the product conforms with the EU directives for CE marked products.

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