SOFTWARE QSR DOCUMENTATION AND ITS ROLE IN FDA REGULATORY SUBMISSIONS.

Medical devices benefit from software integration with AI/ML and other features which help modern healthcare achieve improved delivery practices. This new technology creates obstacles in maintaining patient safety together with regulatoryrequirements. This study explores how documentation of software maintains compatibility with both the FDA’s QualityManagement System Regulation and international standards such as IEC 62304, ISO 13485 and ISO 14971

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Publication Details

Journal
Zenodo (CERN European Organization for Nuclear Research)
Published
2025-03-25
DOI
https://doi.org/10.5281/zenodo.15080469
Primary Topic
Healthcare Technology and Patient Monitoring
Type
article
Field-Weighted Citation Impact
0.00
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article

SOFTWARE QSR DOCUMENTATION AND ITS ROLE IN FDA REGULATORY SUBMISSIONS.

Zenodo (CERN European Organization for Nuclear Research)
Healthcare Technology and Patient Monitoring
article

SOFTWARE QSR DOCUMENTATION AND ITS ROLE IN FDA REGULATORY SUBMISSIONS.

article en

Abstract

Medical devices benefit from software integration with AI/ML and other features which help modern healthcare achieve improved delivery practices. This new technology creates obstacles in maintaining patient safety together with regulatoryrequirements. This study explores how documentation of software maintains compatibility with both the FDA’s QualityManagement System Regulation and international standards such as IEC 62304, ISO 13485 and ISO 14971

Zenodo (CERN European Organization for Nuclear Research)
Universidad del Noreste (MX)
Partnerships for the goals
Openalex Percentile: Top 38%
Healthcare Technology and Patient Monitoring
DOIOpen Access PDFOpenAlex
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SOFTWARE QSR DOCUMENTATION AND ITS ROLE IN FDA REGULATORY SUBMISSIONS. · Zenodo (CERN European Organization for Nuclear Research) (2025) | TGRS Research Map | TGRS