Elisabeth A.'s Contact Details

Elisabeth A.'s Company Details

Protocol WritingOur experience in experimental design includes dozens of studies on human subjects including pilot studies, Investigational Device Exemptions (IDEs), FDA mandated Post Market Approval Studies (PMAs), and non-significant risk studies that examine existing medical device indications. We also have experience with combination drug-devices. Biostatistical Analysis We are proficient at analyzing the results of clinical trials, preclinical research, and data mining. 510k Submissions. We are adept at putting 510ks together quickly and efficiently. We can help you to identify predicate devices, present your laboratory test results, clinical data if applicable, and assemble documents for presentation to the FDA.Notified body submissions: dossiers and technical filesFor class I products, we acertain technical files you need are on hand and that they are up to date and ready for audit.Process Validation Process validations are a specialty. We understand the fundamentals of many manufacturing processes. We are inventors, too. Often, we are able to make suggestions to improve your process while we analyze your results.Preclinical Study DesignWe have experience in the entire scope of research required before using your medical device on human subjects, including laboratory testing, accelerated age testing, and animal studies. We can also help you with preclinical risk analysis. Introducing medical devices to the U.S. market.