Do Auditors Read Your Code?
We’re wondering whether our auditor will read the source code of our software. Does that mean we have to choose...
July 24, 2020
Do You Need Video Cameras For User Testing?
We’re currently planning our IEC 62366 - compliant Summative Usability Evaluation, which means that we’ll be doing usability testing with...
July 23, 2020
Software Validation Procedure for ISO 13485 compliance?
We’re currently using GitHub for our code repositories. Now we’ve heard that this sort of software needs to be “validated”....
May 17, 2020
How to document SOUP for IEC 62304 compliance?
Our python backend contains lots of dependencies, for example flask and the requests library. According to the IEC 62304, third-party...
April 29, 2020