Can Product-Specific Assurance Case Templates Be Used as Medical Device Standards?
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.
Bibliographic record
Abstract
International standards are a key ingredient in the quality assurance of software-intensive medical devices. One problem with such standards is that they often describe a lifecycle process that should be used to develop the system, rather than describe acceptance criteria to be applied to the system itself, thus guaranteeing safety directly in terms of the artefact's attributes. In the past few years, the U.S. Food and Drug Administration (FDA) introduced a (strong) recommendation that manufacturers submit an assurance case in their submission for approval to market an infusion pump. This reflects a move toward a more product/evidence-based approach to certification, compared with the primarily process-based certification used in the past. The perceived advantage of an assurance case is that it obliges the manufacturer to make an explicit argument regarding the safety/security/reliability of their product, under expected operating conditions. Taking this idea one step further, we explore whether there are benefits to using an assurance case Template as a new kind of standard, replacing existing process standards, and we describe some benefits of doing this.
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 imitationNot 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.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
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.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from it