{"id":"W1978247000","doi":"10.1115/1.3589903","title":"Development of an ISO 13485 AND FDA QSR Compliant Quality System for an Academic R&amp;D Group: From Concept to Certification","year":2011,"lang":"en","type":"article","venue":"Journal of Medical Devices","topic":"Quality and Safety in Healthcare","field":"Health Professions","cited_by":0,"is_retracted":false,"has_abstract":true,"ca_institutions":"British Columbia Institute of Technology","funders":"","keywords":"Certification; Quality management system; Commercialization; Engineering management; Quality (philosophy); Engineering; Quality management; Multinational corporation; Management system; Business; Operations management; Management; Marketing","routes":{"ca_aff":true,"ca_fund":false,"ca_venue":false,"about_ca":true,"invisible_to_affiliation_only":false},"retraction":null,"screen":null,"direct_labels":[],"prediction":{"model_version":"codex-gemma-dda1882f352a","candidate_categories":[],"consensus_categories":[],"category_scores_codex":[0.006857223,0.0001340432,0.0005916546,0.00008750385,0.000383469,0.000005949756,0.0005000625,0.0004862711,0.0001988528],"category_scores_gemma":[0.000698544,0.0001002126,0.00005404874,0.00009959968,0.00008715024,0.0002570965,0.00007262817,0.000832627,0.0000143958],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.0001373947,"about_ca_system_score_gemma":0.0005976566,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.00122502,"about_ca_topic_score_gemma":0.003268777,"domain_scores_codex":[0.9946948,0.001391747,0.002442621,0.0002182429,0.0009475875,0.0003049779],"domain_scores_gemma":[0.9959641,0.001137171,0.001317661,0.0002151586,0.0004559015,0.0009099813],"domain_codex":null,"domain_gemma":null,"domain_candidate":null,"domain_consensus":null,"study_design_codex":"qualitative","study_design_gemma":"observational","study_design_scores_codex":[0.00325052,0.0009051197,0.07899301,0.01148525,0.0003644942,0.00001301464,0.5987579,0.000002661563,0.004011506,0.03121753,0.001799006,0.2692],"study_design_scores_gemma":[0.002577198,0.0006453788,0.764599,0.006020037,0.0000912558,0.00001802003,0.1770998,0.0004173054,0.0004746652,0.001347568,0.04635509,0.0003546965],"study_design_candidate":"observational","study_design_consensus":null,"genre_codex":"empirical","genre_gemma":"empirical","genre_scores_codex":[0.9834434,0.0007060223,0.01008872,0.004201638,0.0008527016,0.0005380079,0.00008096277,0.00002209291,0.00006641894],"genre_scores_gemma":[0.9737399,0.0000568873,0.02387051,0.001677448,0.0005484041,0.00002909494,0.00005236316,0.0000133468,0.0000121049],"genre_candidate":"empirical","genre_consensus":"empirical","teacher_disagreement_score":0.685606,"threshold_uncertainty_score":0.4086553,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.5347882230117652,"score_gpt":0.552522576505522,"score_spread":0.01773435349375674,"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."}}