ISO 13485:2016 - Design and Development of Medical Devices

ISO 13485:2016 - Design and Development of Medical Devices

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.

1. One PDF file for Slides Presentation: All slides of this course is given with first lecture of this course.

2. 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.

Design and Development of Medical Devices in the perspective of ISO 13485:2016 and Medical Devices Industry

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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?

Rating: 3.96154

Level: Beginner Level

Duration: 2 hours

Instructor: Waqas Imam