What is a file 

What is a file?

The term file often appears in medical device regulations.
For example, the Design History File (DHF: Design History File), Risk Management File (RMF), Usability Engineering File) and complaint files (21 CFR Part 820 §198).
What, then, are the files needed for?
Files are to be compiled by inspectors and third-party certification body auditors to facilitate their investigation in accordance with regulatory requirements and the requirements of international standards.
For example, items related to risk management in medical device design must be compiled in a risk management file.
By examining such files, inspectors and auditors can quickly verify that activities have been carried out in compliance with applicable regulatory requirements and international standards, and that records are adequate.
Thus, files are used to check conformity with each international standard, etc.

However, there is an inclusion relationship for files.
The RMF is encompassed within the DHF and the UEF is encompassed within the RMF.
Files also create a physical binder and do not physically bind documents.
It is an index, so to speak, showing links to each record.
For example, there may be statements in the design documents regarding risk management, as well as usability engineering.
From the RMF, UEF, etc., you point to the chapter number, etc., in which the design document in question is described.

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