The Role of Software in Healthcare - Software in a Medical Device (SiMD) vs. Software as a Medical Device (SaMD): Understanding Regulatory Differences and Expectations

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All About Change

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How do we build an inclusive world? Hear intimate and in-depth conversations with changemakers on disability rights, youth mental health advocacy, prison reform, grassroots activism, and more. First-hand stories about activism, change, and courage from people who are changing the world: from how a teen mom became the Planned Parenthood CEO, to NBA player Kevin Love on mental health in professional sports, to Beetlejuice actress Geena Davis on Hollywood’s role in women’s rights. All About Change is hosted by Jay Ruderman, whose life’s work is seeking social justice and inclusion for people with disabilities worldwide. Join Jay as he interviews iconic guests who have gone through adversity and harnessed their experiences to better the world. This show ultimately offers the message of hope that we need to keep going. All About Change is a production of the Ruderman Family Foundation. Listen and subscribe to All About Change wherever you get podcasts. https://allaboutchangepodcast.com/

לפני שנתיים 35:30

MP3•בית הפרקים

During the discussion, they delve into the differences between SiMD and SaMD, as well as FDA criteria deemed important during evaluation of the safety and effectiveness of device software with one or more device functions.

“I get a lot of questions related to the FDA guidance document. Most sponsors do not really take that guidance document seriously and the FDA does. Every element in that guidance document needs to be considered. ” – Monica Montanez, Principle Product Development Strategist

Discussion topics include:

What criteria are utilized to classify a device as either SiMD or SaMD?
Are certain regulatory agencies taking the lead on future regulations?
How can we better understand digital health trends?

14 פרקים

#Science #Fitness #Medicine #NAMSA

The Role of Software in Healthcare - Software in a Medical Device (SiMD) vs. Software as a Medical Device (SaMD): Understanding Regulatory Differences and Expectations

The RA QA Café

published לפני שנתיים

שתפו

MP3•בית הפרקים

Discussion topics include:

What criteria are utilized to classify a device as either SiMD or SaMD?
Are certain regulatory agencies taking the lead on future regulations?
How can we better understand digital health trends?

14 פרקים

#Science #Fitness #Medicine #NAMSA

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The RA QA Café « » The Role of Software in Healthcare - Software in a Medical Device (SiMD) vs. Software as a Medical Device (SaMD): Understanding Regulatory Differences and Expectations

The Role of Software in Healthcare - Software in a Medical Device (SiMD) vs. Software as a Medical Device (SaMD): Understanding Regulatory Differences and Expectations

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