A Product Risk File is a set of documents or records that provide the regulatory required evidence that a product achieves the performance intended and is designed and manufactured to fulfill its intended purpose. It also provides documented evidence that the product does not compromise safety and the individual and cumulative risks are outweighed by the clinical benefits.
User Rights
The following rights must be assigned to a user for that user to manage or view product risk files:
| Rights | Description |
|---|---|
|
PRF_MANAGE |
Allows the administrator to add new, modify existing, or delete Product Risk Files. |
|
PRF_VIEW |
Allows the user to access and view Product Risk Files. |
NOTE: See Rights Groups for more information on assigning rights groups to users.
See Also
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