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A collection of Regulatory, Guidance and Standards documents relevant for the development of Software-Only Medical Devices

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Software-Only Medical Device References

This is a collection of regulatory, guidance and standards documents relevant for the development of Software-Only Medical Devices in the United States.

"($)" Denotes content is not freely available.

Acknowledgments

This work has been partially funded by the following NIH grants:

  • R42CA183150
  • R42AG062026

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A collection of Regulatory, Guidance and Standards documents relevant for the development of Software-Only Medical Devices

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