
Basic understanding on ISO 13485:2016 International Standard on Design and Development Process in Medical Devices
What you will learn
Students who want to learn the basics about ISO 13485:2016 standard
Students who want to learn the fundamentals of medical devices development process
Description
This is an online awareness course which is for every professional or engineering students; who are looking to learn the new requirements of ISO 13485:2016 on medical devices’ product development process.
Alert >>>> This course is a short version of premium course “ISO 13485:2016 – Design and Development of Medical Devices”. If you have already purchased the premium course, no need to take this course.
Design and development in a quality management system is the most complex part. Similarly in the medical devices sector, design and development is a complex process which involves various roles and phases. Hence this course is engineered to make the process of design and development of medical devices easier for you to understand.
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What you will learn when you take this online course (Course Objectives):
- Introduction to ISO 13485:2016
- FDA Waterfall Model for Design and Development
- Rising Model for Design and Development
- ISO 13485 Requirements on Design and Development
Take this course: Follow the “Take This Course” Button by clicking at the Top Right Hand Side of the Page. Proceed with the instructions and follow it to register the course.