Software development and maintenance lifecycle with the perspective of risk management as per IEC 62304 and FDA
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.
