NAMSA

namsa medical devices medical device iso 10993 biocompatibility fda clinical medical device testing biological evaluation regulatory in vitro leachables postmarket device devices medical material characterization cytotoxicity toxicity genotoxicity chemical characterization shelf life 510(k) pma clinical trial material characterization & analytical chemistry post-market sterilization validation market approval feasibility concept preclinical design validation ethylene chlorhydrin ethylene oxide implantation implant hematology platelets coagulation thrombosis carcinogenicity glp toxicology enviornmental monitoring packaging validation meta analysis cfda irritation tc194 characterization extraction biological safety clinical research statisticians cdrh statistical biostatistician clinical trials biostatistics biostatistic dcc acceptance review type ii error type i error interim analyses interim analysis biocompatibility and peformance of medical devices bpmds safety safety evaluation certification remote training series rts extractables/leachables extractables risk assessment public health advisory food drug and cosmetic act code of federal regulations food and drug administration colorants color additives aami tir 12:2010 post market cleaning disinfection aami tir draft guidance processing reprocessing north american science associates emgp compliance emerging get-to-market global strategy market get to market markets