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Medical Device Regulation (MDR): Intro for Device Designers by Udemy
An introduction to the EU's Medical Device Regulation (MDR) for those involved in developing medical devices
Course Highlights
- The overall requirements and structure of the Medical Device Regulation (MDR)
- Understanding the structure and content of the related international standard on Medical Device Software EN 62304
- Understanding the structure and content of the related international standard on the Application of Risk Management to Medical Devices ISO 14971
- What are the general safety and performance requirements set out in the MDR
Skills you will learn!
Curriculum
1 Topic
Course Overview
4 Topics
Introduction Medical Devices Definition Claims & Standards
General Obligations on Manufacturers
Traceability Classification and Notified Bodies
General Obligations on Manufacturers Quiz
3 Topics
Clinical Evaluations and Clinical Investigations
General Safety and Performance Requirements
Technical Documentation
4 Topics
Software in the MDR & an Introduction to IEC 62304
Software in the MDR & IEC 62304
Risk Management in the MDR & an Introduction to ISO 14971
ISO 14971 Key Points
Medical Device Regulation (MDR): Intro for Device Designers
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