IVDR 2017 746 regulatory affairs: Learn EU compliance

Partner: Udemy
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Description: This Course is broken into nine sections. The objective of the course is to explain the in vitro diagnostic medical device regulation 2017/746 in simple terms:Section 1 Introduction.Introduction to the in vitro diagnostic medical device regulation 2017 746.Why was there a change from the directive to the IVDR 2017 746?The timelines for the transition of the IVDR 2017 746.Section 2 Economic Operator.Economic Operators. Who are they?Economic Operator. The European Authorised representative. Explain their obligation.Economic Operator. The Distributor. Explain their obligation.Economic Operator. The Importer. Explain their obligation.Economic Operator. The Manufacturer. Explain their obligation.When does an Economic operator obligation change?Explain the obligation of a person responsible for regulatory complianceSection 3 EUDAMEDIntroduction to what EUDAMED is.Understand what is meant by the actor registration.The timelines for the transition of EUDAMED systemSection 4 Unique Device Identification and registrationUDI Introduction. What is it? Why is it needed?UDI The Carrier. Understand the unique device identification carrier.UDI Accredited Organisation. Understand who the current accredited organisations are that can create Unique Device identification carrier standards.UDI timelines. When the UDI carrier needs to be attached to the packaging and devices.Section 5 Classification of in vitro diagnostic medical devicesQualification of in vitro diagnostic medical devices. Determine if the manufacturer is making a medical device.Classification of in vitro diagnostic medical devices Introduction.Understand in vitro diagnostic medical device definitions. This will help the student how to classify a medical device.
Category: Business > Industry > Medical Device Development
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Price: 199.99
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Source: Impact
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