French company Ubiplug, a designer and developer of medical devices to enhance the healthcare of patients undergoing vascular access procedures, has obtained ISO 13485:2016 certification for its Quality Management System (QMS).

Compliance with international regulatory and normative requirements for medical devices allows Ubiplug to begin global marketing of its patented smart valve system that makes haemodialysis procedures easier.

Ubiplug’s smart valve system for vascular access procedures is based on a fluid management multichannel connection technology. The company’s first application is in haemodialysis, a complex treatment performed several times per week to enable people to live with the chronic kidney disorder: End-Stage Renal Disease (ESRD). 

“ISO 13485:2016 certification for Ubiplug’s QMS is a significant achievement. The compliance with normative and regulatory requirements ensures ‘Safety and Performance’ of our medical devices,” said Eric Jean, CEO of Ubiplug. “This certification also gives us the green light on several company activities. We are in position to start our first in-human clinical investigation, followed by the launch of our smart valve system.”

Ubiplug’s smart valve system is a single-connection device that manages all the necessary steps required to carry out a standard Central Venous Catheter (CVC) procedure. In practice, this means that a nurse directly handles the haemodialysis catheter only once, as opposed to the dozen hand manoeuvres usually made. With Ubiplug’s proprietary innovative technology almost all these individual hand manoeuvres are eliminated as the nurse can now switch haemodialysis session steps without having to open the haemodialysis catheter. Revolutionary in its design, Ubiplug’s smart valve system offers the all-important advantage of minimizing patient exposure to the main sources of potentially life-threatening infections.