Course Description

Complaint Handling and Reporting Process for Medical Devices

Course Description:

This course provides a comprehensive overview of complaint handling and an outline of the reporting process for commercially-released medical devices.

It focuses on the following topics:

  • Product safety assurance
  • Basic principles of the complaint handling and reporting processes
  • The complaint handling cycle
  • Adverse event reporting in the post market phase

Learning Objectives:

Upon successfully completing this course, trainees will be able to:

  • Define what constitutes a complaint
  • Distinguish when a complaint or adverse event is reportable
  • Comprehend and apply a high-level Product Safety Assurance Model and know where the complaint handling process fits into this cycle
  • Understand the importance of having the appropriate resources within your Complaint Handling Unit to ensure that all complaints are properly reviewed and assessed based on risk severity
  • Identify which agencies require an adverse event to be reported
  • Acknowledge that all adverse events should be reported within a designated time period to the applicable agencies

Who Should Enroll:

Regulatory Affairs Associate, Regulatory Affairs Manager, Quality Assurance Associate, Quality Assurance Manager, Quality Assurance Engineer, Manufacturing Engineer, Supply Manager, Purchasing Manager, Design Engineer, Validation Engineer, Electrical Safety Engineer, Internal Auditor, Lead auditor, Pre-Clinical Study Manager, Export Manager, Clinical Affairs Director, and R&D Engineer are all encouraged to take this course.

Prerequisite Knowledge/Requirements:

There is no prerequisite knowledge required for this course; all areas of expertise are welcome.

Subject Matter Expert:

65 min

Related resources:

Case studies:

Basic Account: € 211.00
Premium Account: € 158.00

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