Vigilance Procedure
SKU:
SOP 8-009
$149.00
$149.00
per item
The Vigilance Procedure provides instruction on classifying incidents to determine reportability and instruction on overall reporting process. The Vigilance Procedure Includes a Vigilance Decision Tree.
- ISO 13485:2016 Compliant
- MDR EU 2017/745 Compliant
- MS Word Format
- Instant Download Digital Content
Vigilance ProcedureThe Vigilance Procedure provides instruction on requirements for reporting on serious incidents and field safety corrective actions. The Vigilance Procedure Includes vigilance decision tree and related forms.
Vigilance Procedure OverviewThe Vigilance Procedure, and applicable decision trees, will determine if the incident meets the three basic reporting criteria in order for an incident to be classified as reportable and provides instruction on how to report a reportable incident.
Vigilance Procedure ComplianceThe Vigilance Procedure is MEDDEV 2.12-1, Medical Device Regulation, Health Canada, Medical Device Regulation MDR 2017/745 and ISO 13485:2016 compliant.
For more information about our Vigilance Procedure contact us at info@aplyon.com
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