Preparing a High-Quality MD Dossier
This module will provide an overview on how to propose a new MD filing to the USFDA/EU/IMDRF. It will touch upon good documentation practices, and document content as per the EU Medical Device Regulation MDR 2017/745. Further, it will highlight industry examples with documentation.
English
100% Online
60 Minutes
APACMed Certificate
Assessments
Interactive
About Preparing a High-Quality MD Dossier
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About this Module
Why should I enrol in this Module?
This module will provide an overview on how to propose a new MD filing to the USFDA/EU/IMDRF. It will touch upon good documentation practices, and document content as per the EU Medical Device Regulation MDR 2017/745. Further, it will highlight industry examples with documentation.
Who should enrol in this Module?
This Module is suitable for all Pre-Market professionals or anyone with an interest in creating a high quality Medical Device Dossier.
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, true and false, 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.