Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Considerations

Name: Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Considerations
Creator: International Medical Device Regulators Forum
Keywords: considerations,framework,imdrf,medical-devices,risks,samd,software,software-as-a-medical-device

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Original link

Type

Technical document

Regulated products

Medical Devices

Last updated

September 18, 2014

Description

Technical document: IMDRF/SaMD WG/N12FINAL:2014

Organization

International Medical Device Regulators Forum (IMDRF) 🌍

Country / Region

Worldwide

License

Other (Public Domain)

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2 Main files

Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Considerations

Updated on September 18, 2014

pdf (242.6KB)

URL: https://www.imdrf.org/sites/default/files/docs/imdrf/final/technical/imdrf-tech-140918-samd-framework-risk-categorization-141013.pdf
Permalink: https://data.openrid.co/en/datasets/r/352655ba-f606-469d-aad3-6f2654728438
MIME Type: application/pdf

Created on: September 18, 2014
Modified on: September 18, 2014

Size: 242.6KB

IMDRF code: IMDRF/SaMD WG/N12FINAL:2014

Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Considerations

Updated on September 18, 2014

docx (175.6KB)

URL: https://www.imdrf.org/sites/default/files/docs/imdrf/final/technical/imdrf-tech-140918-samd-framework-risk-categorization-141013.docx
Permalink: https://data.openrid.co/en/datasets/r/1fca5e4d-5d55-4854-8250-be265c5b0d68
MIME Type: application/vnd.openxmlformats-officedocument.wordprocessingml.document

Created on: September 18, 2014
Modified on: September 18, 2014

Size: 175.6KB

IMDRF code: IMDRF/SaMD WG/N12FINAL:2014

Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Considerations

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