Abstract: This present disclosure relates to a system and method to manage compliance of regulated products. The system and method for managing compliance of regulated products includes qualitative and analysis of data obtained from within a company, across many companies, and from third party data sources to determine correlation, relevance, and importance of data points, as they relate to determining quality events, possible outcomes, risks and alerts, for the products.

Abstract: This present disclosure relates to a system and method to manage compliance of regulated products. The system and method for managing compliance of regulated products includes qualitative and analysis of data obtained from within a company, across many companies, and from third party data sources to determine correlation, relevance, and importance of data points, as they relate to determining quality events, possible outcomes, risks and alerts, for the products.

Abstract: A catheter assembly for use in extracorporeal treatment of a bodily fluid. The catheter assembly includes a catheter body having an outer tubular member and an inner tubular member. At least one of the tubular members includes an expansion member, such as a malecot, for centering the catheter assembly in a body vessel. Body fluid is withdrawn from the vessel, and passed through one of the tubular members to a treatment instrument, such as a dialyzer. Treated fluid from the treatment instrument is then passed through the other tubular member and returned to the body vessel through one or more openings in said other tubular member.