Complaint Handling and Vigilance Procedure
This 12-page procedure provides a number of benefits, including:
- Defines criteria used to determine if an event meets the definition of a complaint as defined by the US FDA.
- Criteria are provided to determine if a particular event requires a Medical Device Report (MDR)
- Establishes requirements for the uniform and timely investigation of events.
- Describes the documentation required when an MDR is mandated.
Work Instruction for Documenting Complaint Information
This 18-page work instruction document describes requirements related to documenting a suspected complaint electronically using the company’s complaint handling system (Argos Global Sentinel™ Software), or manually using form F-00211, Complaint Notification Form, which is also included. It also provides directions for completing a Good Faith Effort (GFE) to obtain additional information where required.
Plus receive a Standard Vigilance Decision Tree
If you are interested in purchasing a procedure for complaint handling and vigilance reporting that is in MS Word Format, Medical Device Academy has a complete set of procedures available for purchase and download. Click here to visit our procedures page.