Documenting compliance with IEC 62304 in medical device software development
Have you ever felt that you are having trouble with finding a way how to actually apply the requirements of IEC 62304 within your organization? The good news is, you are not alone. This is a very common issue since the standard does not require implementing any...
Risk control measures in medical device software
If you work in the medical device industry, then you know software risk management is not to be taken easy. The following video comes from our online course Introduction to software for medical devices and IEC 62304 and it might help clear some of the tricky details...
Medical device software risk management and IEC 62304 terminology
Risk is a word we see daily. We all know what it means. However, when it comes to a specific situation, i.e., developing software that needs to be safe, risk is something you need to understand thoroughly to deal with risk management properly. You need good risk...
Introduction to different classifications rules for medical device software
If you are working with software for medical devices, you will inevitably have to deal with different classifications. In a larger company, there will be more people around you, but if you are working for a smaller one, all that burden may be yours. This is by no...
Medical device design control terminology
When you are presented with a medical device product development project, you do not want to have to ask what the intended use, user needs, design input, design verification, and design validation means. You will learn about this and many more things in the video...
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