Ubiplug receives ISO13485 certification for QMS

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), which was issued by DNV - Accredia. 

Compliance with international regulatory and normative requirements for medical devices allows Ubiplug to begin marketing, to global markets, its patented smart valve system that makes haemodialysis procedures easier. Ubiplug acquired the certification in less than a year, marking the first of four major milestones the company wishes to achieve in 2022. 

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 hemodialysis, a complex treatment performed several times per week to enable people to live with the chronic kidney disorder: End-Stage Renal Disease (ESRD). There are more than 1.4m ESRD patients in the US and Europe.

Eric Jean, CEO of Ubiplug, said: “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. We are proud to offer such quality to patients and healthcare professionals, who are our main focus. 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 for improved healthcare is the result of a collaboration with the University Hospital CHU Caen, AP-HP (Europe’s largest public hospital system located in Paris) and Air Liquide Healthcare. The commercial launch of Ubiplug’s first product is earmarked for Q3, 2022. 

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 once, as opposed to the dozen hand manoeuvres usually made. Thanks to Ubiplug’s proprietary innovative technology - covered by five patents and CE marking certified - 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 minimising patient exposure to the main sources of potentially life-threatening infections.