{"title":"Integrated Safety and Risk Assessment for Medical Devices and Combination Products","authors":"S. Gad","doi":"10.1007/978-3-030-35241-7","DOIUrl":"https://doi.org/10.1007/978-3-030-35241-7","url":null,"abstract":"","PeriodicalId":432972,"journal":{"name":"Integrated Safety and Risk Assessment for Medical Devices and Combination Products","volume":"2 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2020-02-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"129975440","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Regulatory Aspects and Strategy in Medical Device and Biomaterials Safety Evaluation","authors":"S. Gad","doi":"10.1007/978-3-030-35241-7_2","DOIUrl":"https://doi.org/10.1007/978-3-030-35241-7_2","url":null,"abstract":"","PeriodicalId":432972,"journal":{"name":"Integrated Safety and Risk Assessment for Medical Devices and Combination Products","volume":"1 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2018-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"128802424","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Where the Data Is and What Is It?","authors":"S. Smith","doi":"10.1007/978-3-030-35241-7_5","DOIUrl":"https://doi.org/10.1007/978-3-030-35241-7_5","url":null,"abstract":"","PeriodicalId":432972,"journal":{"name":"Integrated Safety and Risk Assessment for Medical Devices and Combination Products","volume":"20 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"1900-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"128177550","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Toxicity of Common Extractables and Leachables of Medical Devices","authors":"Kandice M. Nappier, Sherri Smith","doi":"10.1007/978-3-030-35241-7_12","DOIUrl":"https://doi.org/10.1007/978-3-030-35241-7_12","url":null,"abstract":"","PeriodicalId":432972,"journal":{"name":"Integrated Safety and Risk Assessment for Medical Devices and Combination Products","volume":"53 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"1900-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"131615996","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Biocompatibility Testing: The Biologic Tests","authors":"S. Gad","doi":"10.1007/978-3-030-35241-7_3","DOIUrl":"https://doi.org/10.1007/978-3-030-35241-7_3","url":null,"abstract":"","PeriodicalId":432972,"journal":{"name":"Integrated Safety and Risk Assessment for Medical Devices and Combination Products","volume":"13 21","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"1900-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"114044458","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"An Introduction to (Q)SAR with Respect to Regulatory Submissions","authors":"J. Bettis","doi":"10.1007/978-3-030-35241-7_8","DOIUrl":"https://doi.org/10.1007/978-3-030-35241-7_8","url":null,"abstract":"","PeriodicalId":432972,"journal":{"name":"Integrated Safety and Risk Assessment for Medical Devices and Combination Products","volume":"46 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"1900-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"128435681","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Pathology and Histopathology Evaluations of Biomaterials and Medical Devices","authors":"J. Schuh","doi":"10.1007/978-3-030-35241-7_9","DOIUrl":"https://doi.org/10.1007/978-3-030-35241-7_9","url":null,"abstract":"","PeriodicalId":432972,"journal":{"name":"Integrated Safety and Risk Assessment for Medical Devices and Combination Products","volume":"48 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"1900-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"132270920","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Integrated Safety Assessment of Medical Devices","authors":"S. Gad","doi":"10.1007/978-3-030-35241-7_11","DOIUrl":"https://doi.org/10.1007/978-3-030-35241-7_11","url":null,"abstract":"","PeriodicalId":432972,"journal":{"name":"Integrated Safety and Risk Assessment for Medical Devices and Combination Products","volume":"1 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"1900-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"124281495","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Considerations for Leachables and Extractables Testing","authors":"Amy L. Mihalchik-Burhans, E. N. Rogers","doi":"10.1007/978-3-030-35241-7_4","DOIUrl":"https://doi.org/10.1007/978-3-030-35241-7_4","url":null,"abstract":"","PeriodicalId":432972,"journal":{"name":"Integrated Safety and Risk Assessment for Medical Devices and Combination Products","volume":"50 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"1900-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"115526541","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Bridging Issues of Route","authors":"Amy L. Mihalchik-Burhans, D. Sullivan","doi":"10.1007/978-3-030-35241-7_6","DOIUrl":"https://doi.org/10.1007/978-3-030-35241-7_6","url":null,"abstract":"","PeriodicalId":432972,"journal":{"name":"Integrated Safety and Risk Assessment for Medical Devices and Combination Products","volume":"6 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"1900-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"122270251","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}