RISK MANAGEMENT IN IVD PRODUCER, RELATION BETWEEN MANUFACTURER AND USER

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Boutorabi Seyyed Mehdi

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Seminar Paper

Paper Information

Seminar: CONGRESS ON QUALITY IMPROVEMENT IN CLINICAL LABORATORIES
Year:2016 | Issue:14

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Title

RISK MANAGEMENT IN IVD PRODUCER, RELATION BETWEEN MANUFACTURER AND USER

Author(s)

Boutorabi Seyyed Mehdi

Keywords

RISK MANAGEMENT

IVD MANUFACTURER

CLINICAL LABORATORY

Abstract

IVD MEDICAL DEVICE MANUFACTURERS ARE GENERALLY REQUIRED TO HAVE A QUALITY MANAGEMENT SYSTEM AS WELL AS PROCESSES FOR ADDRESSING DEVICE RELATED RISKS. THE IVD MANUFACTURER SHALL ESTABLISH, DOCUMENT AND MAINTAIN THROUGHOUT THE LIFE-CYCLE AN ONGOING PROCESS FOR IDENTIFYING HAZARDS ASSOCIATED WITH AN IVD MEDICAL DEVICE, ESTIMATING AND EVALUATING THE ASSOCIATED RISKS, CONTROLLING THESE RISKS, AND MONITORING THE EFFECTIVENESS OF THE CONTROLS...

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APA: Copy

Boutorabi, Seyyed Mehdi. (2016). RISK MANAGEMENT IN IVD PRODUCER, RELATION BETWEEN MANUFACTURER AND USER. CONGRESS ON QUALITY IMPROVEMENT IN CLINICAL LABORATORIES (9TH INTERNATIONAL & 14 NATIONAL CONGRESS). SID. https://sid.ir/paper/930487/en

Vancouver: Copy

Boutorabi Seyyed Mehdi. RISK MANAGEMENT IN IVD PRODUCER, RELATION BETWEEN MANUFACTURER AND USER. 2016. Available from: https://sid.ir/paper/930487/en

IEEE: Copy

Seyyed Mehdi Boutorabi, “RISK MANAGEMENT IN IVD PRODUCER, RELATION BETWEEN MANUFACTURER AND USER,” presented at the CONGRESS ON QUALITY IMPROVEMENT IN CLINICAL LABORATORIES (9TH INTERNATIONAL & 14 NATIONAL CONGRESS). 2016, [Online]. Available: https://sid.ir/paper/930487/en

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