Is Your Usability Engineering File in Order?

Is Your Usability Engineering File in Order?

As a former medical device business analyst, and current editor of the True Process blog, I am always interested in articles that help companies achieve success in the medical device development process. In my job, I do a lot of research and I have been struck by the quality of information at Mindflow Design’s blog. In particular, I found their recent post on the Usability Engineering File interesting.

The Usability Engineering File is an FDA-required component of most 510(k) premarket notification filings. While it is a key component of the Design History File, its function is often relegated to a “check-off” task completed at the end of the project. Unfortunately, this defeats the intention of the requirement. Read Mindflow’s article for tips on using your Usability Engineering File as a tool to help your regulatory filing (and product) be successful!




Learn How to Use Outsourcing to Make Your Health IT Projects Soar!

If you are looking to outsource software development, engineering, or prototyping, you need to download the new infographic put together by the team at True Process. This downloadable resource covers the why, the who, and the how of IT outsourcing for the healthcare industry.
Download the Outsourcing Infographic