Guide to Field Safety Corrective Actions for Medical Devices and In-vitro Diagnostic Medical Devices

Name: Guide to Field Safety Corrective Actions for Medical Devices and In-vitro Diagnostic Medical Devices
Creator: Health Products Regulatory Authority
Keywords: actions,changes,diagnostics,field-safety-corrective-action,fsca,guidances,guide,in-vitro-diagnostic-medical-devices,in-vitro-diagnostics,ivd,ivdmd,ivds,medical-devices,procedures,safety,tracking

Information

Original link

Type

Guidance

Regulated products

IVDMD, Medical Devices

Published

June 9, 2014

Last updated

June 9, 2014

Description

A guidance document outlining procedures for Field Safety Corrective Actions for Medical Devices and In-vitro Diagnostic Medical Devices.

Organization

Health Products Regulatory Authority (HPRA) 🇮🇪

Country / Region

Ireland

License

Other (Public Domain)

Feedback

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2 Main files

sur-g0001-guide-to-field-safety-corrective-actions-for-medical-devices-and-in-vitro-diagnostic-medical-devices-v5.pdf

Updated on June 9, 2014

pdf (147.0KB)

URL: https://www.hpra.ie/docs/default-source/publications-forms/guidance-documents/sur-g0001-guide-to-field-safety-corrective-actions-for-medical-devices-and-in-vitro-diagnostic-medical-devices-v5.pdf?sfvrsn=12
Permalink: https://data.openrid.co/en/datasets/r/5dc59dc6-dbb5-4ccc-8408-5dd5b0e1e986
MIME Type: application/pdf

Created on: June 9, 2014
Modified on: June 9, 2014

Size: 147.0KB

SUR-G0001 Guide to Field Safety Corrective Actions for Medical Devices and In-vitro Diagnostic Medical Devices v5 changes tracked

Updated on May 8, 2024

pdf

URL: https://www.hpra.ie/docs/default-source/tracked-changes-documents/sur-g0001-guide-to-field-safety-corrective-actions-for-medical-devices-and-in-vitro-diagnostic-medical-devices-v5-changes-tracked.pdf?sfvrsn=2
Permalink: https://data.openrid.co/en/datasets/r/cb722c1a-2e48-4627-87a4-353df97a5458
MIME Type: application/pdf

Created on: June 9, 2014
Modified on: May 8, 2024