Summative evaluation is the final evaluation of your product’s user interface and confirmation that it does not result in an unacceptable risk to people. Essentially, it is the stage where you get to see if your whole usability engineering process was successful.
Providing basic documentation for all OTS software is expected. The documentation needs to consist of several points which answer the questions such as — what is it, what does it do, etc. Documentation serves as a piece of evidence.
Software system, item and units often cause both discussion and confusion. The blog post will try and clarify these within the terminology.
When it comes to the use of CVSS, it is by no means limited to non-medical software, which means that the answer to the question from the title is yes, it can be used for medical device software too.
This blog post tries to explain and help you understand how to manage your choice of the development process and documenting compliance with IEC 62304.
When working with medical device software, some of the most important things include knowing how to identify risks, and how to implement risk control measures in medical device software. The article provides an overview.
Risk is something you need to understand thoroughly to deal with risk management properly.
You need good risk management because it is a regulatory requirement, you can avoid killing your patients, and it helps you understand on which areas to focus the most.
Take a look at our online Risk Management course on ISO 14971:2019 and online Design Control for Medical Devices course.
These courses are taken by both competent authorities, notified bodies and medical device manufacturers and distributors.
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