Failure Investigation Procedure
The Failure Investigation Procedure defines the process of conducting a failure investigation when a medical device fails to me product performance specifications. Failure investigations are intended to determine root cause for failure and to provide adequate solutions to correct and prevent problems from reoccurring.
- ISO 13485:2016 Compliant
- FDA QSR Compliant
- MS Word Format
- Includes Related Forms
- Digital Content - Instant Download
Failure Investigation ProcedureThe Failure Investigation Procedure defines the process of conducting a failure investigation when a medical device fails to me product performance specifications.
Failure Investigation Procedure - OverviewThe Failure Investigation Procedure applies to product performance failures. The procedure applies to but is not limited to the following circumstances:
The Failure Investigation Procedure provides instruction on investigation initiation, execution, and closure processes. The procedure includes report forms and a remedial action decision tree.
Failure Investigation Procedure - ComplianceThe Failure Investigation Procedure is ISO 13485:2016 and FDA QSR compliant
For more information about our Failure Investigation Procedure contact us at [email protected]
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Failure Investigation Procedure
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