System, item and units in medical device software
No matter what type of work one does, it is essential to know the terminology right. We have already written about the importance of knowing one’s terminology here, and now we are going to deal with a different type. The video below is the second part of this topic...
Security: can CVSS be used for medical device software?
A part of working in medical device software is security risk assessment. Another one is safety risk assessment. These two require great attention, and should not be done separately, as they are often related to one another. There is a dilemma when it comes to this....
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...
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