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Essentials of European Medical Device Regulations (EU MDR) - 2017/745
Essentials of European Medical Device Regulations (EU MDR) - 2017/745

What You Will Learn In This Free Course
- Explain the three directives on med...
- Discuss the transformation of old E...
- Summarize the important improvement...
- Differentiate the different classes...
- Explain the three directives on medical devices: IVDD, MDD & AIMDD
- Discuss the transformation of old EU directives into new regulations, and their relationships
- Summarize the important improvements with the new EU MDR
- Differentiate the different classes of medical devices and the criteria for classification
- List the 22 rules of product classification for a medical device
- Interpret the route to market for medical devices in Europe
- Evaluate the roles of different economic operators in EU
- Describe the applications and requirements of EU-UDI
- Specify the requirements on EUDAMED in EU MDR
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Learners Who Took This Course Also Enrolled In
- ISO 13485:2016 - Quality Management Systems for Medical Devices
- ISO 14971:2019 - Risk Management Application on Medical Devices
- 21 CFR Part 820 - Fundamentals of Quality System Regulation (QSR)
- Fundamentals of US FDA Medical Device Submission Process
- Fundamentals of EU IVDR Regulations for In-Vitro Medical Devices
- ISO 9001:2015 - Quality Management System (QMS)
- Good Clinical Practice - ICH Guidelines E6 R2
- Fundamentals of Six Sigma (6σ) - Six Sigma White Belt