This guide will break down the regulatory terms and help you understand SaMD and the IEC 82304-1 standard. It discusses AI, ML, continuous integration and continuous deployment (CI/CD) when developing software as a medical device (SaMD).
This illustrated guide provides a useful overview of IEC 62304, clarifies terminology used in the standard, and addresses common misconceptions in medical device software development.
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.
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
If you are developing medical device software, then you will be working closely with the IEC 62304 standard. The number of activities you need to complete according to the standard depend on how harmful your medical device is. This
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.