Risk Classification of Medical and In-vitro Devices

This module will define medical devices and in-vitro diagnostic devices. It will also provide guidance on the IMDRF risk classification system and its rules while show casing risk classification systems  in selected IMDRF jurisdictions. Furthermore, it will provide a series of examples and studies to demonstrate the application of rules-based risk classification for IVD medical devices.

English

100% Online

90 minutes

APACMed Certificate

Assessments

Interactive

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This module has been co-developed by Yiting Cai

This module has been co-developed by Dr. Adelheid Schneider

About this Module

Purpose
Learning Objectives
Target Audience
Module Structure
Assessment
Certificate

Why should I enrol in this Module?

This module will define post-market surveillance and explain why it is important. It will also provide guidance on adverse event reporting within the vigilance system and outline vigilance prerequisites and post-market surveillance. It will close with an update on post-market surveillance harmonisation efforts.

Who should enrol in this Module? 

This Module is suitable for all Regulatory Affairs professionals or anyone with an interest in the regulation of medical devices.

How is this Module structured?

This is a self-paced, interactive Module.  It is divided into a number of individual topics so you can easily track your progress and manage your time.

You must watch all of the videos and presentations before the section will be marked as complete.

You can view the structure and individual topics below.

What kind of assessment do I need to do?

This Module contains a number of short knowledge checks and a final assessment.  

You will have unlimited attempts to pass each knowledge check.

What will I learn?

By the end of this module, you will have an understanding of:

  • the definition of medical devices and in-vitro diagnostic devices
  • the rules-based classification of medical devices and in-vitro diagnostic devices
  • how to classify  medical devices in selected key IMDRF member countries
  • how to classify IVD medical devices as per the IMDRF rules-based risk classification model.

When will I get my certificate?

At the completion of the course you will immediately have access to the certificate from APACMed.