Each manufacturer shall establish and maintain procedures to ensure that the design requirements relating to a device are appropriate and address the intended use of the device, including the needs of the user and patient. The procedures shall include a mechanism for addressing incomplete, ambiguous, or conflicting requirements. The design input requirements shall be documented and shall be reviewed and approved by designated individual(s). The approval, including the date and signature of the individual(s) approving the requirements, shall be documented.
!Attention points
* Design inputs are often referred to as [[Requirements]]
* Among the activities that need to be documented are:
** Intended use
** User needs
** Patient needs
** A mechanism for addressing incomplete, ambigious or conflicting requirements
** Design and development interfaces
* A good mechanism to control design input documentation is a [[Design Input Document Control Matrix]]
!Attention points
Possible mechanisms to control input requirements include the following:
* A detailed [[Design Input Requirements Control Matrix]]
* Detailed input documents
bag
fda_public
created
Sun, 22 Jul 2012 18:37:36 GMT
creator
dirkjan
modified
Sun, 22 Jul 2012 18:37:36 GMT
modifier
dirkjan
tags
CFR
CFR 21-820.30
Design Controls
FDA
Quality System Requirements
Section
creator
dirkjan