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To ring in the new year, https://medgroup.biz/pre510k. This is a three-hour replay and the 108 slides from David Amor and Jon Speer’s presentation at last year’s 10x Medical Device Conference. We’re making them available this week for $59 (guests paid $325 to attend). The price will be $89 next week. If you’re even thinking about doing a 510(k) submission this year, access and share this work with your team. It includes: Notes: • A “good” question: “Does the FDA agree with the planned usability and human factors evaluation studies?” • “Bad” questions: “What testing should I do?” and “Is my product code MAO?” and “How many samples should I use for DV?” • David and Jon stressed how FDA likes standardization. They gave very detailed examples of what to (and not to) do when getting FDA counsel. • I had to laugh; the breath of their talk covered broad issues like defining system architecture and the tiniest detail like, “to which human should I mail this?” The presentation was gloriously comprehensive. If you can’t get these guys on your team, at least get this gift they prepared for Medical Devices Group members. See https://medgroup.biz/pre510k and a big thank you to David and Jon! +++ I’ll be in Orange County on Jan 22 for Dan Golka’s MED TECH MONDAY, sharing my top medical device marketing insights for 2018. Also: Join me: https://medgroup.biz/MTM-Jan18 +++ Make it a great week – and year! Joe Hage Joe Hage Sherri Gallagher Marked as spam
 Posted by Asked on January 2, 2018 11:27 pm
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