Corpus ID: 237532343

Risk Management of AI/ML Software as a Medical Device (SaMD): On ISO 14971 and Related Standards and Guidances

@article{Odaibo2021RiskMO,
  title={Risk Management of AI/ML Software as a Medical Device (SaMD): On ISO 14971 and Related Standards and Guidances},
  author={Stephen G. Odaibo},
  journal={ArXiv},
  year={2021},
  volume={abs/2109.07905}
}
Safety and efficacy are the paramount objectives of medical device regulation. And in line with the medical ethos of non-maleficence, first do no harm, safety is the primary goal of regulation also. As such, risk management is the underlying principle that governs the regulation of medical devices, whether traditional devices or Software as a Medical Device (SaMD). In this article, I review how Risk Management Standard ISO 14971:2019 both connects with and serves as a foundation for the other… Expand

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References

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Study on Implementation Approach for Standard YY/T 0316(ISO 14971) "Medical Devices-Application of Risk Management to Medical Devices"
TLDR
The risk management of medical devices and the development history of the standard "YY/T 0316 Medical devices-Application of risk management to medical devices" is introduced and the implementation approach is proposed. Expand
Deciding When to Submit a 510(k) for a Software Change to an Existing Device -FDA
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