{"id":"W7108076371","doi":"10.5281/zenodo.17772657","title":"Comparative analysis of supply chain risk management strategies for in-vitro diagnostic devices: Regulatory requirements and harmonization approaches in the USA, Canada, and Europe","year":2025,"lang":"","type":"article","venue":"Zenodo (CERN European Organization for Nuclear Research)","topic":"Quality and Safety in Healthcare","field":"Health Professions","cited_by":0,"is_retracted":false,"has_abstract":true,"ca_institutions":"","funders":"","keywords":"Supply chain; Harmonization; Food and drug administration; Agency (philosophy); Risk management; Risk assessment; Supply chain risk management; Supply chain management","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":[0.01879849,0.0004859938,0.0004991838,0.004674879,0.001690693,0.003919864,0.001521787,0.0009138102,0.001175931],"category_scores_gemma":[0.02641524,0.0003093469,0.001021409,0.005259191,0.001649933,0.001732502,0.001710341,0.0006379933,0.00009916899],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.04305526,"about_ca_system_score_gemma":0.04302224,"about_ca_topic_candidate":true,"about_ca_topic_consensus":true,"about_ca_topic_score_codex":0.5432006,"about_ca_topic_score_gemma":0.5498165,"domain_scores_codex":[0.9803898,0.006573057,0.000769445,0.001006459,0.009317308,0.001943892],"domain_scores_gemma":[0.9630686,0.01350019,0.003643698,0.001073836,0.01808745,0.0006262089],"domain_codex":null,"domain_gemma":null,"domain_candidate":null,"domain_consensus":null,"study_design_codex":"design_other","study_design_gemma":"observational","study_design_scores_codex":[0.001470906,0.001366885,0.3169142,0.00231733,0.001018133,0.0011748,0.01622982,0.1974689,0.008957122,0.1083269,0.00496726,0.3397878],"study_design_scores_gemma":[0.0001822325,0.00250678,0.7109258,0.001496797,0.001401686,0.0004906687,0.05678701,0.146357,0.01687093,0.0127059,0.04999097,0.0002843141],"study_design_candidate":"observational","study_design_consensus":null,"genre_codex":"empirical","genre_gemma":"empirical","genre_scores_codex":[0.917329,0.003364853,0.03369047,0.001564264,0.00002423291,0.001289873,0.0007613835,0.00009786058,0.04187802],"genre_scores_gemma":[0.9857361,0.001313783,0.0105731,0.0001511697,0.000004493523,0.0001520302,0.0004093976,0.00001482558,0.001645149],"genre_candidate":"empirical","genre_consensus":"empirical","teacher_disagreement_score":0.4567994,"threshold_uncertainty_score":0.9189792,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.1653490279186529,"score_gpt":0.36545564977179,"score_spread":0.2001066218531372,"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."}}