Documentation for a medical device product development process (Part 1)
This article covers the typical document deliverables that you will have in a medical device product development project. Bear in mind that this is merely a simplified overview to help you understand the flow of information and the logic behind the process, as well as...
How to perform the summative evaluation for medical devices (IEC 62366-1)
In IEC 62366-1:2015, the term “formative evaluation” appears twenty-eight times. “Summative evaluation”, on the other hand, is mentioned a total of fifty-four times. That information alone speaks volumes about the importance of summative evaluation.The video below is...
Managing and documenting SOUP and OTS in medical device software
Documentation is a crucial process in essentially everything you do – it serves as a piece of evidence, and it also helps you keep track of everything that has been done and has to be done. The same goes for SOUP and OTS within medical device software. The video below...
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....
Medical Device HQ
In-house training, public and online courses on managing and developing safe medical devices
