Medical Device Regulation 2017/745 EU regulatory affairs.

Partner: Udemy
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Description: This Course is broken into nine sections. The objective of the course is to explain the medical device regulation 2017/745 in simple terms:Section 1 Introduction.Introduction to the Medical device regulation 2017 745.Why was there a change from the directive to the MDR 2017 745?The timelines for the transition of the MDR 2017 745. How the COVID pandemic has impact these timelinesSection 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.Economic Operator. The Procedure pack & Systems Provider. 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 Part 1. What is it? Why is it needed?UDI Part 2. Understand the unique device identification carrier.UDI Part 3. 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 medical devicesClassification of medical devices Introduction.Qualification of medical devices. Determine if the manufacturer is making a medical device.Understand medical device definitions. This will help the student how to classify a medical devi
Category: Business > Industry > Medical Device Development
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Price: 199.99
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Source: Impact
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