IEC 62304 - Medical Devices Software Development & Processes
What you'll learn
- Comprehend the IEC 62304 standard and what elements are there in software lifecycle processes
- Illustrate the FDA guidance along with IEC 62304 and compare the types of softwares and risks involved
- Compare the level of risks iterated in FDA guidance on medical device software and IEC 62304 and how do they coorelate
- Demonstrate your understanding about different types of medical device softwares
Requirements
- A basic understanding of medical device and softwares operating within that industry
Description
IEC 62304 standard explains the life cycle requirements for medical device software. The different processes, interrelated activities, and measures are described in this standard which develops an international protocol for standard processes related to medical device software life cycle. As the medical device itself is critical product therefore the software associated with it should also be dealt in a serious controlled manner.
This course on IEC 62304 is the first interactive course on medical devices software development. It will empower you to understand how to create and maintain safe software for medical devices throughout their life cycles. You will gain a robust understanding of important terminologies to allow you to comprehensively participate in discussions about software safety classifications and software risk management. Along with this, you should also assimilate how IEC 62304 interacts with other standards such as ISO 14971, ISO 13485, IEC 60601 series.
You will have unlimited access to the course and its educational materials. The great value within our online courses is that you can pause, re-watch and start again watching online lectures where you actually stopped. You can do this as many times as you like without any limitation whatsoever! This offers you with the comfort to learn what, how, where and when you want.
No need to pay thousand dollars for one day awareness course on the design and development of medical devices software. This course will suffice your requirement.
You will learn the about this new standard IEC 62304 requirements on software lifecycle development.
You will be taught following when you take this course (Course Objectives):
Basic information about the IEC 62304
Process for Software Development
Safety Classification
Documentation
Risk Management Process
Configuration Management
Problem Resolution
FDA, IMDRF Classification for SAMDs
COPYRIGHT NOTICE: Please note that this IEC 62304 standard is IEC copyright protected. A standard copy will NOT be issued with this course. However we offer all our presentation materials in PDFs to be downloaded. You can use the presentation material for your own learning without sharing it to someone else without permission.
Practice Exam: The course also comes with a practice exam to let you analyze yourself about the software lifecycle development.
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. Auditors can also inquire for your training on the IEC 62304. With this course, obviously you will have a professional course certificate (from Udemy) to show if you are inquired about this during. Therefore you can confidently answer the auditor whether you know IEC 62304 or not.
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.
One Month Money Back Guarantee: Don't forget, this Course have comes with One Month 100% Money Back Guarantee. This means you have unconditionally no risk when registering to this 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:
- The course is relevant for any professional working with software development, such as R&D engineers, quality assurance department and auditors of software development.
- All those working in compliances for medical devices industry and want to extend their knowledge on software medical devices
- Consultants working to support their clients on medical devices' software compliances
- The course does not comprise of actual coding, rather compliance guidelines on software development. So don't expect that we will teach coding.
Instructors
- 4.0 Instructor Rating
- 1,389 Reviews
- 18,037 Students
- 8 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.
- 4.1 Instructor Rating
- 3,706 Reviews
- 47,486 Students
- 40 Courses
Exoexcellence is established to suffice the intellectual gap in the market for management system consultancy and training. This profile is an endeavour of the Training Department of Exoexcellence. The Exoexcellence 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 understand 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.