MétaCan
Menu
Back to cohort

Linking Medical Device Assurance Cases

2025· article· W4416873946 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.
fundA Canadian funder is recorded on the work.

Bibliographic record

Venuenot available
Typearticle
Language
FieldEngineering
TopicSafety Systems Engineering in Autonomy
Canadian institutionsMcMaster UniversityMcMaster University Medical Centre
FundersNatural Sciences and Engineering Research Council of Canada
KeywordsTraceabilityCertificationQuality assuranceMedical deviceTrustworthinessKey (lock)Patient safety

Abstract

fetched live from OpenAlex

Traceability and assurance cases (ACs) are crucial for certification of medical devices built on product line platforms. Prone to inconsistencies in handling product lines, monolithic ACs can complicate traceability of claims, arguments and evidence. We previously introduced the separation of assurance for certain medical devices into two linked ACs: a Technological Assurance Case (TAC), addressing system safety concerns disregarding clinical effects on patients; and a Clinical Assurance Case (CAC), addressing safety of a clinical application. A key observed gap is the absence of traceability that links them to extend their utility. We now propose a traceability metamodel as part of TACTICS (Traceable Assurance Cases for Trustworthy Integrated Compliance and Safety), a model-based methodology to support traceability across multiple assurance cases. We present an overview of this traceability process, conceptually, using a TAC/CAC for a medical system as an example, discussing its benefits, challenges and limitations.

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)0.001
metaresearch head score (Gemma)0.001
Version: codex-gemma-dda1882f352aValidation status: machine_predicted_unvalidated
Candidate categoriesMeta-epidemiology (narrow), Insufficient payload (model declined to judge)
Consensus categoriesnone
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Simulation or modeling · Consensus signal: Simulation or modeling
GenreCandidate signal: Empirical · Consensus signal: none
Teacher disagreement score0.977
Threshold uncertainty score1.000

Codex and Gemma teacher scores by category

CategoryCodexGemma
Metaresearch0.0010.001
Meta-epidemiology (narrow)0.0010.001
Meta-epidemiology (broad)0.0010.000
Bibliometrics0.0000.001
Science and technology studies0.0000.000
Scholarly communication0.0000.000
Open science0.0010.000
Research integrity0.0010.001
Insufficient payload (model declined to judge)0.0010.001

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 head0.011
GPT teacher head0.249
Teacher spread0.238 · 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

Quick stats

Citations0
Published2025
Admission routes2
Has abstractyes

Explore more

Same topicSafety Systems Engineering in AutonomyFrench-language works237,207