Back To Basics: Complaints, Regulatory Reporting, and Recalls

Build a post-market system regulators trust and teams can execute with consistency.

What You’ll Gain

By the end of this course, you will 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

What’s Included

  • Six focused training modules
    Step-by-step lessons covering complaint handling, feedback triage, regulatory reporting decisions, field actions, and procedure integration.
  • Real-world regulatory workflow
    Learn how complaints move from intake through evaluation, MDR decision-making, investigation, and potential field action.
  • Practical regulatory guidance
    Clear explanations of expectations under QMSR, ISO 13485:2016, 21 CFR Part 803 (MDR), and 21 CFR Part 806 (Corrections and Removals).
  • Decision-making frameworks
    Understand how to classify feedback vs complaints, evaluate reportability, and document decisions so they remain defensible during inspections.
  • Procedure and system design insights
    Learn how to structure procedures, forms, and workflows that connect complaint handling with CAPA, risk management, and management review.
  • Downloadable reference materials
    Practical resources you can use as working references when reviewing or updating your own procedures.
  • Knowledge check and certificate
    Confirm your understanding with a course quiz and receive a certificate of completion.
  • One year of access
    Return to the lessons anytime for reference while updating procedures, training teams, or preparing for audits.

Who This Course Is For

  • On-Demand Video Lessons – Expert-led training covering QMSR structure, design controls, supplier management, CAPA, and compliance strategies.
  • Templates and Cheatsheets – Essential regulatory documents, including audit checklists, CAPA templates, and QMS roadmaps.
  • Downloadable Resources – Practical guides on QMSR requirements, FDA inspection preparation, and ISO 13485 alignment.

This course is designed for:

  • Quality Assurance professionals
  • Regulatory Affairs specialists
  • Post-market surveillance teams
  • Quality and regulatory leaders responsible for complaint systems

It is especially useful for organizations updating procedures under QMSR alignment with ISO 13485:2016.

Start building a complaint and reporting system that regulators trust.

Enroll today to gain immediate access to the course.

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