ISO 13485:2016 - Awareness on Medical Devices Development

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


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.

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.

Who this course is for:

  • Professionals in medical devices industry
  • Medical and Bio-medical Engineering students
  • Professionals passionate about medical devices industry
  • Quality professionals
  • Research and development professionals
  • Product Development Professionals
 -  ISO 13485:2016 - Awareness on Medical Devices Development
  • Udemy teacher
  • English
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  • 1180
  • 2022-03-06