🔥 Find me at MedicalDevicesGroup.net 🔥
2 min reading time
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:
• 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!
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