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104 -New FDA Guidance, HF vs. Design Validation, Critical Tasks & Pre-IND HF Studies with Sara McNew
Manage episode 378056399 series 3325357
Content provided by Subhi Saadeh. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by Subhi Saadeh or their podcast platform partner. If you believe someone is using your copyrighted work without your permission, you can follow the process outlined here https://player.fm/legal.
On this episode, I was joined by Sara Waxberg MacNew, Chief Scientific Officer at Design Sciences. On this episode Sara and I discuss:
- New FDA Guidance:
- Critical Task Definition for Combination Products
- Pre-Clinical HF Studies in readiness for IND Submission
- URRA
- Human Factors Validation vs. Design Validation
Sara Waxberg McNew is the Chief Scientific Officer at Design Science, a human factors firm that specializes in healthcare. Sara has held roles previously in user centered design leadership at Eli Lilly, Philips Healthcare, and Baxter Healthcare. She is an active member of AAMI where she has contributed to the development and revision of human factors technical information reports and international standards. Learn more about Design Science's impact on Healthcare Technology by following @designscience on all social media platforms.
149 episodes
104 -New FDA Guidance, HF vs. Design Validation, Critical Tasks & Pre-IND HF Studies with Sara McNew
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Manage episode 378056399 series 3325357
Content provided by Subhi Saadeh. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by Subhi Saadeh or their podcast platform partner. If you believe someone is using your copyrighted work without your permission, you can follow the process outlined here https://player.fm/legal.
On this episode, I was joined by Sara Waxberg MacNew, Chief Scientific Officer at Design Sciences. On this episode Sara and I discuss:
- New FDA Guidance:
- Critical Task Definition for Combination Products
- Pre-Clinical HF Studies in readiness for IND Submission
- URRA
- Human Factors Validation vs. Design Validation
Sara Waxberg McNew is the Chief Scientific Officer at Design Science, a human factors firm that specializes in healthcare. Sara has held roles previously in user centered design leadership at Eli Lilly, Philips Healthcare, and Baxter Healthcare. She is an active member of AAMI where she has contributed to the development and revision of human factors technical information reports and international standards. Learn more about Design Science's impact on Healthcare Technology by following @designscience on all social media platforms.
149 episodes
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Similar to Combinate Podcast - Combining Drugs and Devices
How can we, humans, look at our relationship to nature differently? In season three of Going Wild, on top of stories about animals, we invite you to journey through the entire ecological web — from the tiniest of life forms to apex predators — alongside the scientists, activists and adventurers who study it. Wildlife biologist and host Dr. Rae Wynn-Grant has been studying wild animals in their natural habitats all over the world for years. Our award-winning podcast takes you inside the hidde ...
…
continue reading
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…
continue reading
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…
continue reading
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…
continue reading
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…
continue reading
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…
continue reading
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…
continue reading
Artificial Intelligence has suddenly gone from the fringes of science to being everywhere. So how did we get here? And where's this all heading? In this new series of Science Friction, we're finding out.
…
continue reading
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…
continue reading
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…
continue reading
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Go offline with the Player FM app!
Go offline with the Player FM app!
