{"id":"W6930690290","doi":"10.5281/zenodo.15110211","title":"Implementation of Design Controls: Regulatory Strategy for Compliance with Health Canada and FDA Requirements for Medical Devices","year":2025,"lang":"en","type":"article","venue":"Zenodo (CERN European Organization for Nuclear Research)","topic":"Psychological Testing and Assessment","field":"Psychology","cited_by":0,"is_retracted":false,"has_abstract":true,"ca_institutions":"","funders":"","keywords":"Compliance (psychology); Cornerstone; Quality (philosophy); Health care; Quality management; Recall; Closing (real estate); Conformity assessment","routes":{"ca_aff":false,"ca_fund":false,"ca_venue":false,"about_ca":true,"invisible_to_affiliation_only":true},"retraction":null,"screen":null,"direct_labels":[],"prediction":{"model_version":"metacan-v3-hybrid-931329e0061c","candidate_categories":[],"consensus_categories":[],"category_scores_codex":[0.1742207,0.001409516,0.0005505153,0.006392032,0.004881362,0.01221661,0.005317227,0.007746574,0.003475328],"category_scores_gemma":[0.1794596,0.0008914504,0.001256731,0.002379406,0.007660928,0.003787452,0.00394964,0.006398262,0.001247143],"about_ca_system_candidate":true,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.03486681,"about_ca_system_score_gemma":0.1547474,"about_ca_topic_candidate":true,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.1452967,"about_ca_topic_score_gemma":0.1484817,"domain_scores_codex":[0.7913457,0.05332095,0.01235916,0.01258451,0.1199273,0.01046236],"domain_scores_gemma":[0.7397527,0.08365069,0.038922,0.01826083,0.1108441,0.008569683],"domain_codex":null,"domain_gemma":null,"domain_candidate":null,"domain_consensus":null,"study_design_codex":"design_other","study_design_gemma":"not_applicable","study_design_scores_codex":[0.0006306667,0.002362797,0.0480877,0.001415247,0.0002508132,0.0004583423,0.008425932,0.004883763,0.02292852,0.232936,0.08984337,0.587777],"study_design_scores_gemma":[0.001171844,0.006098399,0.2595739,0.006000108,0.0006023641,0.001857459,0.00785982,0.01904333,0.06460102,0.07193473,0.5603026,0.0009545088],"study_design_candidate":"not_applicable","study_design_consensus":null,"genre_codex":"other","genre_gemma":"methods","genre_scores_codex":[0.1587053,0.01099981,0.2009028,0.2453819,0.002174135,0.01404319,0.0009199824,0.005474168,0.3613987],"genre_scores_gemma":[0.8026066,0.001468342,0.1120989,0.05087034,0.0004062451,0.002892606,0.0005263192,0.0004183464,0.02871237],"genre_candidate":"methods","genre_consensus":null,"teacher_disagreement_score":0.9651332,"threshold_uncertainty_score":0.9213781,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.1578052890477999,"score_gpt":0.4142029245260379,"score_spread":0.256397635478238,"validation_status":"score_only:v0-immature-baseline","note":"Baseline scores from an immature model (maturity gate not passed). Scores rank; they never assert a category."}}