ISO 13485:2016 – Design and Development of Medical Devices

ISO 13485:2016 – Design and Development of Medical Devices, available at $49.99, has an average rating of 4.1, with 17 lectures, 1 quizzes, based on 434 reviews, and has 1113 subscribers.

You will learn about What is ISO 13485:2016? What is the "design and development" of a medical device? What are the steps of "design and development" of a medical device? How to manage the "design and development" in a life-cycle of medical device? FDA Waterfall model for design and development Unique rising model for design and development according to ISO 13485 This course is ideal for individuals who are Quality Management staff who are new in medical devices sector or Any one who is working or wants to work in the Product Development of medical devices or Research and development professionals or beginners in medical devices industry or Medical engineers who opt to work in a medical devices industry or Professional looking to learn ISO 13485:2016 or Any person who wants to his/her career in the medical devices industry It is particularly useful for Quality Management staff who are new in medical devices sector or Any one who is working or wants to work in the Product Development of medical devices or Research and development professionals or beginners in medical devices industry or Medical engineers who opt to work in a medical devices industry or Professional looking to learn ISO 13485:2016 or Any person who wants to his/her career in the medical devices industry.

Enroll now: ISO 13485:2016 – Design and Development of Medical Devices

Summary

Title: ISO 13485:2016 – Design and Development of Medical Devices

Price: $49.99

Average Rating: 4.1

Number of Lectures: 17

Number of Quizzes: 1

Number of Published Lectures: 17

Number of Published Quizzes: 1

Number of Curriculum Items: 19

Number of Published Curriculum Objects: 19

Number of Practice Tests: 1

Number of Published Practice Tests: 1

Original Price: $49.99

Quality Status: approved

Status: Live

What You Will Learn

What is ISO 13485:2016?
What is the "design and development" of a medical device?
What are the steps of "design and development" of a medical device?
How to manage the "design and development" in a life-cycle of medical device?
FDA Waterfall model for design and development
Unique rising model for design and development according to ISO 13485

Who Should Attend

Quality Management staff who are new in medical devices sector
Any one who is working or wants to work in the Product Development of medical devices
Research and development professionals or beginners in medical devices industry
Medical engineers who opt to work in a medical devices industry
Professional looking to learn ISO 13485:2016
Any person who wants to his/her career in the medical devices industry

Target Audiences

Quality Management staff who are new in medical devices sector
Any one who is working or wants to work in the Product Development of medical devices
Research and development professionals or beginners in medical devices industry
Medical engineers who opt to work in a medical devices industry
Professional looking to learn ISO 13485:2016
Any person who wants to his/her career in the medical devices industry

This is a premium quality course on design and development of medical devices as per ISO 13485:2016 and best industrial practices. ISO 13485:2016 is the international standard for the quality management system of medical devices’ manufacturers and suppliers. The standard name is also entitled with an additive expression “For Regulatory Purposes”. It means the standard is designed in a way to help companies in meeting the regulatory requirements as well.

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.

The rising model based on ISO 13485:2016 requirements of design and development is only taught in this course. Rising model is developed by the instructor of this course and is therefore unique way of explaining the ISO 13485 requirements on design and development.

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
Design and Development Planning
Design and Development Procedure
Design and Development Inputs
Design and Development Outputs
Design and Development Review
Design and Development Verification
Design and Development Validation
Design and Development Transfer
Design and Development Changes
Design and Development Files
ISO 13485 Requirements on Design and Development

No need to pay thousand dollars for one day awareness course on the design and development of medical devices. This course will suffice your requirement.

You will learn the about this new standard ISO 13485:2016 requirements on design and development.

NOTICE: Please note that this ISO 13485:2016 standard is ISO copyright protected. A standard copy will NOT be issued with this course.

Amazing Offer – Resource Materials:There are two free resources which are exclusively given in this courses.

One PDF file for Slides Presentation: All slides of this course is given with first lecture of this course.
One PDF file for rising model of design and development: The unique Rising model based on ISO 13485:2016 requirements on design and development is available with the second lecture.

Practice Exam:The course also comes with a practice exam to let you analyze yourself about the awareness of design and development taught in this course.

Certification:A certificate is also available with this course. Once you complete all lectures and successfully pass the exam, you can have your certificate of successful completion of this course.

One Month Money Back Guarantee:Don’t forget, this Course have without inquiry, One Month 100% Money Back Guarantee. This means you have unconditionally no risk when registering to this Course.

Certificate Issuance Alert from Exoexcellence:Many students have complained that they do not want the new Udemy Certificate (template issued last year). Rather, they wanted the older one. We have communicated their concern to Udemy’s management. But please note that is their standard and they are not going to change that for now. So in order to satisfy the need of our students, we have a designed certificate (which is being issued from Exoexcellence Training Resources) which seems satisfactory to our students; raising the concerns. Therefore, now we have a system within the course where you can request a certificate from us after completing the course.

Ask Questions & Report Complaints:Discussion forum on the right side of this course can be used to discuss specific queries and report problems you are facing about the content of the course.

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 and pay for the course.

Course Curriculum

Chapter 1: Introduction to ISO 13485:2016 & Medical Devices Design and Development Process

Lecture 1: Introduction to ISO 13485:2016 and its requirements on Design and Development

Lecture 2: Important Notes: Guidance for New Students at Udemy

Lecture 3: Important Notes: Guidance for New Students

Lecture 4: Two Models for Explanation of Design and Development process of Medical Devices

Chapter 2: Design and Development Planning and Procedure

Lecture 1: Design and Development of Procedure

Lecture 2: Design and Development Planning

Chapter 3: Design and Development Inputs and Outputs

Lecture 1: Design and Development Inputs

Lecture 2: Design and Development Outputs

Chapter 4: Design and Development Reviews, Verification and Validation

Lecture 1: Design and Development Review

Lecture 2: Design and Development Verification

Lecture 3: Design and Development Validation

Chapter 5: Design and Development Transfer, Changes and Files

Lecture 1: Design and Development Transfer

Lecture 2: Design and Development Changes

Lecture 3: Design and Development Files

Chapter 6: ISO 13485:2016 Specific Auditable Requirements on Design and Development

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

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

Chapter 7: Practice Exam

Lecture 1: Certificate Application Form

Instructors

Waqas Imam
Industrial Engineer | IRCA Auditor | Medical Devices Expert
Exoexcellence Training Resources
Management System, Process Excellence, Lean & Six Sigma

Rating Distribution

1 stars: 17 votes
2 stars: 24 votes
3 stars: 109 votes
4 stars: 164 votes
5 stars: 120 votes

Frequently Asked Questions

How long do I have access to the course materials?

You can view and review the lecture materials indefinitely, like an on-demand channel.

Can I take my courses with me wherever I go?

Definitely! If you have an internet connection, courses on Udemy are available on any device at any time. If you don’t have an internet connection, some instructors also let their students download course lectures. That’s up to the instructor though, so make sure you get on their good side!

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