{"id":"W6968475891","doi":"10.5281/zenodo.15110210","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":"Pharmaceutical industry and healthcare","field":"Pharmacology, Toxicology and Pharmaceutics","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":["metaresearch"],"consensus_categories":[],"category_scores_codex":[0.1900191,0.001650587,0.0007537643,0.007168749,0.005479903,0.01595449,0.006313252,0.009854838,0.003436946],"category_scores_gemma":[0.1660558,0.001157258,0.001595416,0.002859382,0.008917433,0.004861222,0.00471441,0.00741027,0.001312786],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.04844153,"about_ca_system_score_gemma":0.2250482,"about_ca_topic_candidate":true,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.2024213,"about_ca_topic_score_gemma":0.1846944,"domain_scores_codex":[0.758766,0.05079224,0.01343236,0.01432497,0.1490767,0.01360763],"domain_scores_gemma":[0.7498605,0.06683517,0.03527897,0.01706484,0.1217183,0.009242195],"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":[0.0005489844,0.001919084,0.03639746,0.001686908,0.0003016602,0.0006272955,0.007752429,0.006145814,0.02030471,0.3180943,0.0976695,0.5085518],"study_design_scores_gemma":[0.001071941,0.005265903,0.1596142,0.006469151,0.000608985,0.001807934,0.007036061,0.01598865,0.05087251,0.0816835,0.6686342,0.0009468817],"study_design_candidate":"not_applicable","study_design_consensus":null,"genre_codex":"other","genre_gemma":"methods","genre_scores_codex":[0.1123666,0.01225581,0.1806441,0.2851841,0.00210824,0.01296278,0.0009319034,0.004440058,0.3891065],"genre_scores_gemma":[0.751947,0.00221478,0.1285603,0.07598983,0.0004849055,0.003018703,0.0006584961,0.0004191547,0.03670678],"genre_candidate":"methods","genre_consensus":null,"teacher_disagreement_score":0.7975787,"threshold_uncertainty_score":0.9988506,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.4617677913925257,"score_gpt":0.530884699761374,"score_spread":0.06911690836884832,"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."}}