Dirkjan: Created page with "A ''Design Input Requirements Control Matrix'' is a Controlled Document that identifies in a tabular format each device input requirements. The matrix..."

2020-08-25T07:19:14Z

Created page with "A ''Design Input Requirements Control Matrix'' is a Controlled Document that identifies in a tabular format each device input requirements. The matrix..."

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A ''Design Input Requirements Control Matrix'' is a [[Controlled Document|Controlled Document]] that identifies in a tabular format each device input requirements. The matrix may be devided into individual sections for major elements of the input requirements. For example:
* Intended use
* User needs
* Patient needs
* Operational requirements
* Standard requirements
* Safety requirements
* Performance requirements
* Environmental requirements
* Labelling requirements
* Packaging requirements
* Documentation requirements
The document will be subject to version control.
[[Category:fda]]

[[Category:CFR 21-820.30]]

[[Category:Design Controls]]

[[Category:FDA]]

[[Category:Quality System Requirements]]

[[Category:Section]]

Design Input Requirements Control Matrix - Revision history

Dirkjan: Created page with "A ''Design Input Requirements Control Matrix'' is a Controlled Document that identifies in a tabular format each device input requirements. The matrix..."