Essential Principles-
General Safety and Performance Requirements(IVDR)

This module will address Essential Principles (EPs) across jurisdictions and explore the relevance of the Essential Principles' checklist as a tool in design and development of IVDs. This module also discusses the general requirements and those specific to in-vitro diagnostic devices within the context of Essential Principles and explains confidence in clause compliance by way of examining the role of standards.

English

100% Online

60 minutes

APACMed Certificate

Assessments

Interactive

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This module has been developed by
Dr. Melissa Robins

About this Module

Purpose
Learning Objectives
Target Audience
Module Structure
Assessment
Certificate

Why should I enrol in this Module?

This module will address Essential Principles (EPs) across jurisdictions and explore the relevance of the Essential Principles' checklist as a tool in design and development of IVDs. This module also discusses the general requirements and those specific to in-vitro diagnostic devices within the context of Essential Principles and explains confidence in clause compliance by way of examining the role of standards.

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:

  • Essential Principles across jurisdictions
  • the Essential Principle checklist as tool in design and development of IVDs
  • the general general requirements and those specific to IVDs
  • the confidence in clause example by way of illustrating the role of standards

When will I get my certificate?

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