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The FDA Readiness Assessment is a packaged service offering designed to provide a thorough and independent assessment of a company’s readiness to submit their Medical Device Software Development product to the FDA for approval.

Instrument Demonstrations

This is a demonstration of the Rheonix software. The video shows how our software interacts with the machine. The software is touchscreen capable. The software you see in the video is a recorded simulator developed by RND. The Encompass is for research use only at this time.

This is a video of our RND simulator of the GenePOC software, showing how it interacts with the Revogene. The software is touchscreen, the mouse is only there to help with the video.

Misc.

This episode was presented by two of our incredible 2020 summer interns, Claire Graves and Alyssa Flint who are pre-med and medical students. They came to us to present on medical terminology that is helpful to know when we deal with them on behalf of our clients on a daily basis.

With over 20 years experience in regulated software engineering, we’ve built a heritage and reputation for building specialized software with precision and care. We’ve refined our processes and maintained focus to deliver your product as promised.

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