ISO 13485:2016 – Awareness on Medical Devices Development

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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 student; who is looking to learn the new requirements of ISO 13485:2016 on the medical devices’ product development process.

The design and development of a quality management system is the most complex part. Similarly in the medical devices sector, design and development is a complex process that 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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Certification: Udemy does not provide certificates for free courses. But now Exoexcellence is providing a certificate of participation which is available with this course when you complete it. As you complete all lectures successfully, you will be prompted to an activity where you can apply for a certificate. The certificate is usually processed at the end or start of a month.

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 β€œTake This Course” Button by clicking at the Top Right Hand Side of the Page. Proceed with the instructions and follow them to register for 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
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