Complaints, Regulatory Reporting, and Recalls

This course is a practical “back to basics” walkthrough of three topics that create pressure for medical device teams: complaint handling, FDA regulatory reporting, and recalls/corrections and removals. 

You’ll move through the workflow the way it happens in real life. A signal comes in from the field. You decide whether it’s feedback or a complaint. You capture the right information, evaluate what happened, and document your decision trail so it’s clear what was reviewed, what was decided, and why.  

From there, you’ll learn how reportability decisions fit into complaint evaluation, what it takes to maintain MDR readiness under 21 CFR Part 803, and how to handle field actions under 21 CFR Part 806 when a product in the marketplace needs to be corrected or removed. You’ll also cover how to write a single cohesive procedure that ties these pieces together, along with habits that make the system easier to run and defend. 

At a Glance 

• Total Length of Course: 2 hours 

• RAC Points: 2 points

• This course was developed by Michelle Lott and Tianna Benson from LeanRAQA

Learning Objectives 

Upon completion of this course, participants should be able to: 

• Apply the correct complaint definition under QMSR and ISO 13485 

• Distinguish feedback from complaints using clear triage criteria 

• Document complaint evaluation decisions and investigation rationale 

• Evaluate MDR reportability under 21 CFR Part 803 

• Maintain documentation that supports reporting decisions 

• Understand when corrections or removals trigger 21 CFR Part 806 

• Plan recall strategies and effectiveness checks 

• Build procedures and forms that create a repeatable complaint system 

Lesson Titles 

• Lesson 1: Complaints

• Lesson 2: Feedback

• Lesson 3: Regulatory Reporting 

• Lesson 4: Recalls, Corrections, and Removals 

• Lesson 5: Procedure

• Lesson 6: Secrets to Success 

• Lesson 7: Health Hazard Evaluation (HHE) 

This course is also included in:

QMSR Effectiveness Bundle