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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:
• the exact pre-sub timeline;
• what to include and how to format it; and,
• a step-by-step case study example of the pre-sub process.

Notes:
• A pre-sub is akin to calling FDA and saying, “Hey, this is what we’re thinking of doing in product development and regulatory strategy.” Come prepared with good questions; you’ll save time and money.

• 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!

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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:
• Scott Hamilton on the industry outlook
• Michelle Lott on regulatory
• Carl Mayer on manufacturing
… and more, plus a “Women in Medtech” panel, and presentations from startups.

Join me: https://medgroup.biz/MTM-Jan18

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Make it a great week – and year!

Joe Hage
Medical Devices Group Leader

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Joe Hage
🔥 Find me at MedicalDevicesGroup.net 🔥
Thanks for that, Sherri Gallagher. Yes, David and Jon really know their stuff!

Sherri Gallagher
Quality and Industrial Engineering Consultant at Technacon Company Inc
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