Clinical Evidence Requirements - IVDR
This module will provide a broad overview of the differences in In Vitro Diagnostic devices and Medical Devices. The clinical evidence components, clinical performance and evidence level requirements.
English
100% Online
60 Minutes
APACMed Certificate
Assessments
Interactive
About the Regulatory Affairs eLearning Program
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About this Module
Why should I enrol in this Module?
This module will provide a broad overview of the differences in In Vitro Diagnostic devices and Medical Devices. The clinical evidence components, clinical performance and evidence level requirements.
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 in India.
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.
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. They are a combination of multiple choice and role play scenarios.
You will have unlimited attempts to pass each knowledge check.
You will have unlimited attempts to pass each knowledge check.
What will I learn?
When will I get my certificate?
At the completion of the course you will immediately have access to the certificate from APACMed.