Dirkjan: Created page with "In the FDA Regulations description of the '''Design Input Document Control Matrix''' is regarded to be a good mechanism to control design input documentati..."

2020-08-25T07:19:12Z

Created page with "In the FDA Regulations description of the '''Design Input Document Control Matrix''' is regarded to be a good mechanism to control design input documentati..."

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In the [[FDA Regulations|FDA Regulations]] description of the '''Design Input Document Control Matrix''' is regarded to be a good mechanism to control design input documentation:
* By establishing a document that provides overall control to the design input process, firms provide the FDA with a good verification mechanism
* Include a checklist that identifies completed activities (in order to spot incomplete, ambigious or conflicting requirements)
* Elements that should be documented are:
** The purpose oof the device and its intended use
** A description or theory of operation
** Components of the device
** Operational modes
** Prelimairy [[Risk Analysis|Risk Analysis]]
** Controls and alarms
** Interfaces or connectors
** Standards or applicable regulations
** Performance or reliability specifications
** Environmental specifications
** Physical specificatsions
** Safety specifications
** Master verification plan and master validatio pan
** Preliminairy labels and labeling
[[Category:fda]]

[[Category:CFR 21-820.30]]

[[Category:Design Controls]]

[[Category:FDA]]

[[Category:Quality System Requirements]]

[[Category:Section]]

Design Input Document Control Matrix - Revision history

Dirkjan: Created page with "In the FDA Regulations description of the '''Design Input Document Control Matrix''' is regarded to be a good mechanism to control design input documentati..."