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Complaint Handling Training


Complaint HandlingThe PathWise Complaint Handling training explores the process of complaint handling, according to 21 CFR 803, 820, and ISO 13485:2016 and the EU Medical Device Regulations (MDR). It covers the full Complaint Handling process, covering where complaints come from, how to determine if something is a complaint, the complaint investigation process, the complaint reply and closing out the complaint.




Clarify what is classified as a complaint, and where they come from.


Review the Complaint Handling Regulations from:

  • 21 CFR 803
  • 21 CFR 820
  • 21 CFR 820.198
  • ISO 13485:2016
  • Devices Vigilance System, MEDDEV 2.12 rev 8, December 2012
  • EU Medical Device Regulations (MDR) 2017/745


Follow the entire complaint handling process, from beginning to end, including: Receipt of Complaint, Complaint Evaluation, Complaint Investigation, Complaint Response/ MDR Reporting, Closure of Complaint.

These topics covered will have a strong impact on the success of your organization. Our training is highly interactive, with engaging activities, and case studies, to ensure participants understand the concepts.


  • Know a Medical Device Report reportable event.
  • Understand when a complaint is an MDR.
  • Understand all regulations required for Complaint Handling.


  • Understand requirements for complaint handling from receipt to investigation to closure
  • Understand documentation requirements for complaint handling.


Complaint Handling training is appropriate for all employees involved in any step within the complaint handling process.

Instructor Led training- Four Hours interactive instruction.

This course is taught in the classroom with an instructor, using case studies, worksheets, and other interactive activities to ensure learning retention for all learner types. It can be taught as a stand alone course, or as a module together with the Investigations and CAPA full course

Complaint Handling 1/2 day training is worth .4 credits.

PathWise is accredited by the International Association for Continuing Education and Training (IACET).  PathWise complies with the ANSI/IACET Standard, which is recognized internationally as a standard of excellence in instructional practices. As a result of this accreditation, PathWise is accredited to issue the IACET CEU.

TrainingThe most cost effective training option is to have PathWise come to your location. We have trainers across the globe, covering almost every continent!

To schedule a course at your site fill out the form below and a PathWise representative will get back with you shortly!

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We understand that training is essential to achieve and maintain a compliant, effective and efficient quality system. As a result, 90% of our courses are taught on-site at our client’s locations.  For individuals and organizations in need of training but unable to make an on-site training commitment, we offer many of our courses as events at a variety of locations across the globe.

View the PathWise Events page to find out about our options for a public workshop.

Questions about Investigations and CAPA?

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