SKU: SOP 8-009
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
The 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 Overview
The 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.
The criteria are:
1) An event has occurred: This also includes situations where testing performed on the device, examination of information supplied with the device or any scientific information indicated some factor could lead or has led to an event. Events may include but are not limited to the following:
Vigilance Procedure Compliance
The 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 email@example.com
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