INTRODUCTION TO SOFTWARE FOR MEDICAL DEVICES AND IEC 62304 (ONLINE)
ONLINE COURSE
Learn how to be effective in medical device software development during this self paced, interactive online course.
ONLINE COURSE
15-20 hours
Course description
This online course focuses on the process of developing software for medical devices. This includes topics such as how to efficiently plan and document software development, getting requirements right, how to approach software architecture and software risk management, how to perform software safety classification correctly and working with SOUP/OTS software.
It covers all aspects of the IEC 62304 standard and the relationship between the IEC 62304 and other standards such as ISO 14971, IEC 60601-1 and IEC 82304–1.
The course is suitable for anyone working with software development, such as R&D engineers, quality assurance department and auditors of software development. The course does not cover actual coding.
The course is made up of pre-recorded videos, quizzes, and a final exam. You will have access to the course for 6 months from enrolment and will receive a course certificate upon successful completion of the course
Unsure whether this course or the Introduction to SaMD, IEC 62304 and IEC 82304-1 online course is right for you? Go here for a course comparison.
Christian Kaestner is a consultant and entrepreneur with a wealth of knowledge about the medical device industry. He is an expert member of the project team authoring IEC 62304 and also actively participated in the creation of IEC 82304-1.
He has extensive experience of medical device development and, as a software developer, a strong dedication to software development. In the software domain he has worked in many roles such as software developer, project manager, auditing and quality management.
Benefits for you
- Learn from those who wrote the standard
Christian Kaestner is a long time member of the international committee that is authoring the IEC 62304. In his course, you will learn the meaning of the requirements from a first hand source.
- Self-paced learning
- Course certificates to prove to regulatory bodies you know your stuff
Course programme
- Welcome
- What you need to know
- Set you course completion date
- Pre-course assessment quiz
- What is software and what makes it different?
- General software terminology
- Introduction to the regulatory landscape
- Introduction to classification of medical devices and software
- IEC 62304 in relation to other standards
- The gap between IEC 60601-1 and IEC 62304
- IEC 82304-1 – A product standard for health software
- Introduction to risk
- Scope and general terminology – Part 1
- Scope and general terminology – Part 2
- General requirements (IEC 62304)
- Development process and compliance
- Software safety classification – Part 1
- Software safety classification – Part 2
- Software safety classification – Part 3
- Legacy software
- Understanding software risk management
- Development process as risk control – Part 1
- Development process as risk control – Part 2
- Software risk management in IEC 62304 – Part 1
- Software risk management in IEC 62304 – Part 2
- Software causes
- Software risk control measures
- Development planning – Part 1
- Development planning – Part 2
- Development planning – Part 3
- Configuration management
- SOUPs – How to manage and document – Part 1
- SOUPs – How to manage and document – Part 2
- Software requirements – Part 1
- Software requirements – Part 2
- Software architecture – Part 1
- Software architecture – Part 2
- Software detailed design
- Software unit implementation
- Software integration testing
- Software system testing
- Software release
- Maintenance plan
- Problem resolution – the process
- Change control
- Final exam
- Course evaluation
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Frequently asked questions
We offer a number of payment methods including credit card, GooglePay, ApplePay, PayPal, wire transfer/invoice depending on the country you are buying from. If you cannot find your country on the list at checkout or you are not given wire transfer as a payment method, you can submit your order via our invoice order form.
If you purchase five seats for the same online course at the same time, we will give you one extra seat for free on that same course (e.g. buy 5 get 6, buy 10 get 12, etc). The free seat is assigned manually after the order has been received.
Testimonials
Group purchase
You can make a single seat purchase through the shopping cart on Medical Device HQ using a credit card or bank transfer. Please note that, when buying for yourself, the course access is linked to the email address, and the name you enter on checkout.
For a multiple seat purchase, click the button below which will take you to the product page where you can simply enter the number of seats you require.
With a group purchase, we can grant you (or another person you assign) group leader access which enables management of your group, including both adding and removing participants, and receiving progress reports and quiz reports.