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

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לפני שנתיים 35:30

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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

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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

כל הפרקים

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42:01

Risk management is an essential requirement for all medical device organizations when developing, manufacturing, and commercially distributing medical products. In the ninth episode of NAMSA’s RAQA Café Podcast, our hosts sit down with guest speaker Dr. Naveen Agarwal (Principal and Founder of Creative Analytics Solutions, LLC) to discuss valuable insights into Risk Management Systems and best practices for maintaining a Risk Management System. Dr. Agarwal’s mission is to help elevate the collective capability in risk management throughout the medical device industry to accelerate innovation and launch highly safe and effective products for patients and doctors. “...as a risk practitioner, the first conversation we need to have is creating an understanding of what we are trying to accomplish, because its required or its expected... ” – Dr. Naveen Agarwal (Principal and Founder, Creative Analytics Solutions, LLC) Discussion topics include: Developing and maintaining a Risk Management System Having a quality mindset Product Development cycle Helpful Links: Naveen Agarwal, Ph.D. | LinkedIn Effective Implementation of EN ISO 14971 Medical Device Risk Management Standard | NAMSA Industry Update: U.S. FDA Quality Management System Regulation | NAMSA Let's Talk Risk!…

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לפני 2 years41:58

41:58

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54:22

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The RA QA Café

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The Role of Software in Healthcare - Software in a Medical Device (SiMD) vs. Software as a Medical Device (SaMD): Understanding Regulatory Differences and Expectations 35:30

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What are the differences between Software in a Medical Device (SiMD) and Software as a Medical Device (SaMD)? In this third episode of NAMSA's RAQA Café Podcast, our hosts are joined by NAMSA guest speakers, Lezlie Hynes (Principal Quality Consultant) and Monica R. Montanez (Principal Product Development Strategist). 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?…

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36:28

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