Complaint Handling Procedure | ISO 13485 | FDA QSR Compliant
$149.00
$149.00
per item
The ISO 13485 Complaint Handling Procedure governs the process for receiving, reporting, investigating, documenting and closing medical device complaints.
- Comprehensive Complaint Data Capture Form
- Includes Decision Trees (FDA MDR, Canadian, European)
- ISO 13485:2016 Compliant
- FDA QSR Compliant
- MDR EU 2017/745 Compliant
- MS Word Format
- Digital Content - Instant Download
SKU:
SOP 8-001
Complaint Handling ProcedureThe Complaint Handling Procedure governs the process for receiving, reporting, investigating, documenting, and closing medical device complaints.
Complaint Handling Procedure - OverviewThe ISO 13485 Complaint Handling Procedure provides instruction on sources of complaints, how to receive complaints into the system, required complaint information, complaint investigations, complaint closure and the establishment of complaint files.
The Complaint Handling Procedure incudes complaint reporting decision trees. The Complaint Handling Procedure includes FDA MDR, Vigilance, and Canadian reporting decision trees. Complaint Handling Procedure - ComplianceThe ISO 13485 Complaint Handling Procedure is FDA QSR, MDR EU 2017/745 and ISO 13485:2016 compliant.
To learn more about our ISO 13485 Complaint Handling Procedure contact us at [email protected]
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