Free Complaint Handling and Vigilance Procedure, etc.

The complaint handling and vigilance procedure, complaint handling work instruction and vigilance reporting decision tree provided as free downloads were provided by Argos Global. These were provided as free examples. 

%name Free Complaint Handling and Vigilance Procedure, etc.

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. 

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