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Record W1714914045 · doi:10.3233/jid-2005-9405

ANALYSIS OF MEDICAL DEVICES DESIGN REQUIREMENTS

2005· article· en· W1714914045 on OpenAlex

Why this work is in the frame

A frame that forgets how it found something cannot be audited. These are the routes that admitted this work.

affAt least one author lists a Canadian institution in the pinned OpenAlex snapshot.

Bibliographic record

VenueJournal of Integrated Design and Process Science · 2005
Typearticle
Languageen
FieldHealth Professions
TopicQuality and Safety in Healthcare
Canadian institutionsConcordia University
Fundersnot available
KeywordsSystems engineeringComputer scienceEngineering

Abstract

fetched live from OpenAlex

The design and functional complexity of medical devices have increased during the past 50 years. As device functionality is becoming complex, safety, reliability, and comfort are becoming increasingly critical in the medical devices design. Case studies show that the majority of failures of medical devices come from the ignorance of important design requirements in the design stage. Based on the environment-based design model, this paper studies the sources of medical devices design requirements and proposes a systematic approach to guiding the gathering and collection of these requirements.

Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.

Full frame distilled prediction

Teacher imitation

Not calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.

metaresearch head score (Codex)0.017
metaresearch head score (Gemma)0.002
Version: codex-gemma-dda1882f352aValidation status: machine_predicted_unvalidated
Candidate categoriesnone
Consensus categoriesnone
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Simulation or modeling · Consensus signal: none
GenreCandidate signal: Empirical · Consensus signal: none
Teacher disagreement score0.760
Threshold uncertainty score0.778

Codex and Gemma teacher scores by category

CategoryCodexGemma
Metaresearch0.0170.002
Meta-epidemiology (narrow)0.0000.000
Meta-epidemiology (broad)0.0010.000
Bibliometrics0.0010.003
Science and technology studies0.0010.000
Scholarly communication0.0000.001
Open science0.0010.000
Research integrity0.0000.001
Insufficient payload (model declined to judge)0.0010.000

Machine scores (provisional)

The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.

Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.

Opus teacher head0.227
GPT teacher head0.525
Teacher spread0.298 · how far apart the two teachers sit on this one work
Validation statusscore_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from it