EU Medical Device Regulatory Affairs explained Simply
How to get approval to sell Medical Devices within the European Union. Understand regulatory affairs & ISO 13485 2016
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2.5 hours
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Dec 2024
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What you will learn
Understand how Medical Device Regulation works in the European Union.
Differentiate between a regulation and a directive.
Steps required to gain permission to manufacture and sell a medical device in the European Union.
Explain the roles and responsibilities of a Competent Authority & a Notified Body with regard to European Union regulation.
Understand in simple terms the Active Implantable Medical Device Directive 90/385/EEC.
Understand in simple terms the Medical Device Directive 93/42/EEC.
Understand in simple terms the In Vitro Diagnostic Medical Device directive 98/79/EEC
Understand the difference between the directives and the new Medical Device Regulation, MDR EU 2017/745(MDR) & EU 2017/746 (IVDR).
How to obtain CE Marking.
Classification of medical devices in the European Union.
What part does ISO 13485 2016 play in the European Union regulation system.
Understand the part that Manufacturer, the Authorized representative and the EFTA play in the European Union regulation system.
Brexit understand the impact to the European Union regulation.
Understand the transitional time lines from the directives to the medical device regulation.
Understand regulatory affairs
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2658792
udemy ID
11/16/2019
course created date
11/5/2020
course indexed date
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