Instruct: Identify the main and secondary category of Arxiv papers based on the titles and abstracts
Query: Risk Management of AI/ML Software as a Medical Device (SaMD): On ISO
  14971 and Related Standards and Guidances   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 parts of the Artificial
Intelligence (AI)/Machine Learning (ML) SaMD regulatory framework.

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The categories of this paper are: hep-lat
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The categories of this paper are: q-fin
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The categories of this paper are: nucl-ex
18
The categories of this paper are: econ
3
The categories of this paper are: physics
13
The categories of this paper are: quant-ph
4
The categories of this paper are: cond-mat
37
The categories of this paper are: supr-con
21
The categories of this paper are: adap-org
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The categories of this paper are: patt-sol
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The categories of this paper are: dg-ga
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The categories of this paper are: eess
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The categories of this paper are: bayes-an
2
The categories of this paper are: math
8
The categories of this paper are: hep-ex
6
The categories of this paper are: astro-ph