We're just getting started with our medical device documentation, and we initially thought that we need to comply with the...

We're looking for QMS software and don't know which one to choose. Which one is the best QMS software?y...

What's the difference between formative and summative usability testing?...

We are currently developing our software medical device and might be done in 6 months or so. We want to...

We're developing software as a medical device (SaMD), and we're unsure how to perform testing of our software. Should we...

Which Notified Body should we choose?...

We are a University Hospital and developed a medical device software in-house that supports clinical decision making. Can we just...

We're starting to document our processes for ISO 13485 compliance. For that, we're using the OpenRegulatory SOP templates. However, we're...

We'd like to integrate our eQMS with our development tools like e.g. Jira, GitHub, Sharepoint and others. Does that make...

We want to certify our software as a medical device, but we've already developed parts of it (or all of...