29 min listen
Unavailable
Currently unavailable
Regulating Artificial Intelligence and Machine Learning-based Software as a Medical Device
FromGlobal Medical Device Podcast powered by Greenlight Guru
Currently unavailable
Regulating Artificial Intelligence and Machine Learning-based Software as a Medical Device
FromGlobal Medical Device Podcast powered by Greenlight Guru
ratings:
Length:
41 minutes
Released:
Nov 7, 2019
Format:
Podcast episode
Description
Artificial intelligence (AI) and machine learning (ML) seem to be involved in everything, including medical devices and software as a medical device (SaMD). So, regulatory ramifications are possible with such technology and innovation.
In this episode, Allison Komiyama and Michelle Rubin-Onur of Acknowledge Regulatory Strategies discuss regulatory guidance documents related to SaMD created by the International Medical Device Regulators Forum (IMDRF) and U.S. Food and Drug Administration (FDA).
Some of the highlights of the show include:
● IMDRF’s definition of SaMD is software intended to be used or performed for at least one medical purpose without being part of a hardware medical device.
● SaMD field follows four guidance documents that provide key definitions, risk categorization, quality management systems (QMS), and clinical evaluation.
● Manufacturers are encouraged to provide feedback regarding performance, input, and intended use changes and submissions via FDA’s discussion paper.
● When categorizing SaMD, consider the significance of information provided and state of healthcare situation or condition.
● SaMD must undergo a three-step process: Valid clinical association, analytical validation, and clinical evaluation.
● The benefit of using a QMS to understand and mitigate risks helps FDA understand SaMD.
● To Do List: Complete FDA’s call to action; attend Reg AF Conference; and go to Greenlight Guru’s True Quality Roadshow.
In this episode, Allison Komiyama and Michelle Rubin-Onur of Acknowledge Regulatory Strategies discuss regulatory guidance documents related to SaMD created by the International Medical Device Regulators Forum (IMDRF) and U.S. Food and Drug Administration (FDA).
Some of the highlights of the show include:
● IMDRF’s definition of SaMD is software intended to be used or performed for at least one medical purpose without being part of a hardware medical device.
● SaMD field follows four guidance documents that provide key definitions, risk categorization, quality management systems (QMS), and clinical evaluation.
● Manufacturers are encouraged to provide feedback regarding performance, input, and intended use changes and submissions via FDA’s discussion paper.
● When categorizing SaMD, consider the significance of information provided and state of healthcare situation or condition.
● SaMD must undergo a three-step process: Valid clinical association, analytical validation, and clinical evaluation.
● The benefit of using a QMS to understand and mitigate risks helps FDA understand SaMD.
● To Do List: Complete FDA’s call to action; attend Reg AF Conference; and go to Greenlight Guru’s True Quality Roadshow.
Released:
Nov 7, 2019
Format:
Podcast episode
Titles in the series (100)
An Insider’s Look at the Changes Coming in ISO 13485:2016 with Mark Swanson: Did you know ISO 13485 has been revised and approved in 2016? And is going to be published later this month. The quality management standard we’ve all grown to know is now being updated, and we’ll explain more on this episode of the Global Medical De... by Global Medical Device Podcast powered by Greenlight Guru