Software as a Medical Device (SaMD): Application of Quality Management System

Name: Software as a Medical Device (SaMD): Application of Quality Management System
Creator: International Medical Device Regulators Forum
Keywords: applications,imdrf,medical-devices,qms,quality,quality-management-system,samd,software,software-as-a-medical-device

Information

Original link

Type

Technical document

Regulated products

Medical Devices

Last updated

October 2, 2015

Description

Technical document: IMDRF/SaMD WG/N23FINAL:2015

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 (SaMD): Application of Quality Management System

Updated on October 2, 2015

pdf (363.3KB)

URL: https://www.imdrf.org/sites/default/files/docs/imdrf/final/technical/imdrf-tech-151002-samd-qms.pdf
Permalink: https://data.openrid.co/en/datasets/r/db273eac-8259-4661-a787-e42222e08084
MIME Type: application/pdf

Created on: October 2, 2015
Modified on: October 2, 2015

Size: 363.3KB

IMDRF code: IMDRF/SaMD WG/N23FINAL:2015

Software as a Medical Device (SaMD): Application of Quality Management System

Updated on October 2, 2015

docx (748.7KB)

URL: https://www.imdrf.org/sites/default/files/docs/imdrf/final/technical/imdrf-tech-151002-samd-qms.docx
Permalink: https://data.openrid.co/en/datasets/r/44f55dee-b953-42af-9886-31ae42c2aabc
MIME Type: application/vnd.openxmlformats-officedocument.wordprocessingml.document

Created on: October 2, 2015
Modified on: October 2, 2015

Size: 748.7KB

IMDRF code: IMDRF/SaMD WG/N23FINAL:2015

Software as a Medical Device (SaMD): Application of Quality Management System

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