Titan Medical Inc (TMDIF)

[66Mustang]

The initial design freeze is intended to be as close as possible to final production design, but a competent organization has to acknowledge that it might not be perfect, or more requirements may arise. Look at how screwed TRXC was when they hoped for their FDA approval before the Human Factors guidelines were released - it wasn't approved in time so they were on the hook for so much revision that they decided at that time to scrap that project instead of redesign. Those are the same new FDA requirements (as of April 2016) that also kept Ximedica so busy with SPORT this past year. Initial design freeze means they have something ready for testing, and we are on our way forward!

As far as anything that crops up in the meantime, it doesn't necessarily invalidate all the testing done to date. If changes are required, it is acceptable to show the FDA the scope and impact of the changes, and perform regression testing on those changes without having to fully re-validate the entire system.