Role of Standards in Conformity Assessment - ISO,IEC & ASEAN MDD
This module defines standards and their role in the conformity assessment process. It outlines the type and use of standards and provides an overview of global and national recognised standard bodies. This module also discusses the development of standards and their application in the context of the ASEAN Medical Device Directive (AMDD).
English
100% Online
60 minutes
APACMed Certificate
Assessments
Interactive
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This module has been developed by Ed Woo
About this Module
Why should I enrol in this Module?
This module defines standards and their role in the conformity assessment process. It outlines the type and use of standards and provides an overview of global and national recognised standard bodies. This module also discusses the development of standards and their application in the context of the ASEAN Medical Device Directive (AMDD).
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.
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.
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.