Medical Devices QMS - Overview of ISO 13485
This module will introduce the international Quality Management System (QMS) standard for medical devices ISO 13485 and discuss its process approach. The module will elaborate on the structure of ISO 13485 and discuss how it supports medical device manufacturers to ensure that their products consistently meet regulatory and customer requirements.
English
100% Online
60 minutes
APACMed Certificate
Assessments
Interactive
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This module has been developed by Kulveen Singh Bali
About this Module
Why should I enrol in this Module?
This module will introduce the international Quality Management System (QMS) standard for medical devices ISO 13485 and discuss its process approach. The module will elaborate on the structure of ISO 13485 and discuss how it supports medical device manufacturers to ensure that their products consistently meet regulatory and customer 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.
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.