• Post category:StudyBullet-7
  • Reading time:3 mins read


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.


Get Instant Notification of New Courses on our Telegram channel.


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.

English
language

Content

Introduction to ISO 13485:2016 & Medical Devices Design and Development Process

Introduction to ISO 13485:2016 & Medical Devices Design and Development Process
Two Models for Explanation of Design and Development process of Medical Devices

ISO 13485:2016 Specific Auditable Requirements on Design and Development

ISO 13485:2016 Summary Requirements on Design and Development Part 1
ISO 13485:2016 Summary Requirements on Design and Development Part 2
Bonus Lecture