Complaint Handling and Vigilane Reporting Process

General Description

This online & Self-Paced Training Course is focused on compliant management and vigilance reporting process, according to the requirements of EU MDR 2017/745 and IVDR 2017/746. For a more detailed description of the course, refer to the section related to the course contents.

Who Should Attend the course?

This course should be followed by anyone interested in post-market surveillance for medical device sector, and, in any case, anybody working on complaint management and vigilance reporting

Prerequisites

No specific prerequisites are requested to attend this course. However, general knowledge of ISO 13485 and EU MDR / IVDR would be beneficial, although not mandatory or requested.

Structure of the Course

This course is divided into four different sections. At the end of each session, there are some tests and exercises aimed at consolidating the information related to each part of the course. At the very end of the course, a final test can be performed.

Course Certificate

At the end of the course, upon successful completion of all the intermediary and test. Each test shall be passed with a minimum score of 70%.

Course Access

To access the course, you need to first register your account, using the registration area of the website. Training courses can be purchased and attended only after user account creation.

0 – General Introduction to the Course

Course Description and Duration

Structure of the Course

Objective of the Course

Assessment of Learning AchievementsPrerequisite and

Course Certificate

1- Introduction to Complaint Management

Definition of Complaint Handling

Complaint Management Process

Complaint Criteria & Definition of Complaint

2 – Vigilance Reporting Process

Introduction to Article 87 of EU MDR and Timeline for Vigilance Reporting.

Reporting Requirements for Use Error and Abnormal Use

Preparation and Submission of Vigilance Reports

IMDRF Classification of Adverse Events

Vigilance Reporting Requirements in United States and in Australia

3 – Root-Cause Analysis and Complaint Closure

Strategy for Complaints Investigation

Techniques for Root-cause Analysis

Link Between Complaint Management and CAPA Process

Compliant Closure and Communication to Customers

4 – Trend Reports, Analysis of Serious Incidents and Field Safety Corrective Actions.

Trend Reporting Requirements according to EU MDR and IVDR

Examples of Statistical Approach for Trend Reporting

Integrated Process for Trend Reporting

Field Safety Corrective Actions and Field Safety Notice

5 – Post-Market Risk Management

Risk Management, Post-Market Surveillance and Post-Market Clinical Follow-Up.

Management of Production and Post-Production Data

Actions following the review of Post-Production Data

Correlation between ISO 14971, ISO 13485 and ISO/TR 20416.