ISO 13485:2016 - Awareness on Medical Devices Development

Basic understanding on ISO 13485:2016 International Standard on Design and Development Process in Medical Devices
Rating: 3.8 out of 5 (537 ratings)
5,471 students
Students who want to learn the basics about ISO 13485:2016 standard
Students who want to learn the fundamentals of medical devices development process


  • Familiarity with medical devices will be helpful
  • Passion to work in medical devices industry
  • Students should understand English


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

Course content

2 sections5 lectures30m total length
  • Introduction to ISO 13485:2016 & Medical Devices Design and Development Process
  • Two Models for Explanation of Design and Development process of Medical Devices


Industrial Engineer| IRCA Auditor|Medical Devices Expert
Waqas Imam
  • 4.0 Instructor Rating
  • 829 Reviews
  • 6,106 Students
  • 7 Courses

S. M. Waqas Imam is an Industrial Engineer by qualification and has served in the manufacturing industry since 2011. He is also IRCA CQI Lead Auditor.

He had also served as Quality Assurance and Regulatory Affairs Manager in QSA Surgical Pvt. Ltd. and Ultimate Medical Products. He managed requirements of ISO 13485:2003, EU directives, CE marking and FDA.

He also served as expert Blog writer for 13485Academy and wrote expert articles on various topics of ISO 13485:2016.

Recently he is associated with Medical Device Community as Ambassador. He also writes compliance articles on Surgical Units.