In [[CFR 21-820.30f - Design Verification]] and [[CFR 21-820.30g - Design Validation]]. Design verification activities include the following:
* Verification training by the design team
* Pretesting review that consists of a complete and thorough review of the following:
** Design inputs or requirements
** Design outputs or specifications
** Assessments to ensure that the design output or specifications meet the design input or requirements
** Risk analysis and control of identified individual hazards
** All labelling against requirements, specifications and risk analysis including documentaion risk or hazards
* Master [[Verification Plan]] including the following:
** Verification criteria
** Verification assumptions and expectations
** Verification personnel, their qualifications and responsibilities
* Appropriate testing of the following:
** Individual parts elements, components, modules, software components
** All inputs under normal, abnormal and absurd conditions
** Testing deviations or failures
** Deviations or failures after approprate corrective actions
* Equipment calibrated with test equipment and controlled with appropriate requirements
* Master verification and test plans should do the following:
** Consider any [[Premarket notification]] documetation requirements
** Perform according to written and approved master verification plan and test plans
** Ensure identified risks or hazards are fully tested via written test plans
* Documentation that verifies design review and appropriate testing
** Identification of the device
** Methods used in the verification
** Dates
** Individuals performing the verification
** All verification documentation should be considered [[Controlled Document]]ation
* Verification review in which appriopriate individuals review and approve all verifictaion activities, including master verification plan, test plans, test results and any retesting after corrective actions or changes.
bag
fda_public
created
Sun, 22 Jul 2012 13:03:45 GMT
creator
dirkjan
modified
Sun, 22 Jul 2012 13:03:45 GMT
modifier
dirkjan
tags
CFR 21-820.30
Design Controls
FDA
Quality System Requirements
Section
creator
dirkjan