Thursday, November 03, 2016 10:41:53 AM
My questions are specific to the product development and certification.
The biggest open-ended question for me is: "Is their main goal to get the robot certified?
And.... "How are they addressing the steps necessary to get there?"
A) Are all of the previous Ximedica resources assigned back to SPORT? Is Ximedica working with Plexus yet? Has any part of SPORT been handed off to Plexus?
B) What are the minimum number of documented surgical procedures necessary to prove SPORTS "task based" functionality, as compared to the target predicate device? How many are completed? What's the schedule based on the tasks to be completed?
C) What's their view of "the shortest distance between where the development stands today, and the most expeditious path to CE?" Also, does the path to CE affect any of the requirements to FDA certification?
D) When was the last meeting with either agency (ref. CE & FDA), and when are the next meetings scheduled?
Thank you for considering any of these questions, if they are applicable.
Thank you.
Regards,
BK
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