ISO 13485:2016 - Design and Development of Medical Devices
What you'll 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
- Be able to understand english
- Have a good internet connection
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.
Who this course is for:
- 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
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.
Exoexcellence is established to suffice the intellectual gap in the market for management system consultancy and training. This profile is an endeavor of the Training Department of Exoexcellence. The excellence team wants to make sure that high-quality training programs and those which are offered at high-end prices are easily accessible at an affordable cost while keeping the quality of the training material and assessment exercises intact.
Exoexcellence can help professionals in learning and understanding popular international standards with practical exercises and real case studies. Some of the standards in which the Exoexcellence team can help are ISO 9001, ISO 14001, ISO 45001, ISO 50001, ISO 31000, IEC 27001, ISO 13485, ISO 22301, SA 8000, IATF 16949, and other management system standards.