VIPUN Medical is proud to be awarded ISO 13485:2016 certification and announces the inclusion of the first subject in the LOTUS Clinical Investigation at the University Hospital Leuven, Belgium.
Mechelen, Belgium, March 31, 2022 – VIPUN Medical, a company engaged in the development of innovate nutrition devices announces that earlier this month, it was awarded ISO 13485:2016 certification for the Design and Development of systems for monitoring of gastric physiological parameters, and nasogastric tubes for administration and aspiration of nutrition, fluids and medications.
The ISO 13485 Quality Management Standard embodies the requirements for a comprehensive management system for the design and manufacture of medical related devices. ‘With this certification VIPUN Medical demonstrates to the life sciences and medical community its commitment to process and quality control.’ said Carl van Lierde, VIPUN Medical Vice President, Product Development.
Furthermore, VIPUN Medical announces the inclusion of the first subject in the LOTUS Clinical Investigation, by Prof Jan Tack, Principal Investigator of the LOTUS Investigation, at the Translational Research Center for Gastrointestinal Disorders (TARGID) in the University Hospital Leuven. The LOTUS Investigation aims to show that the VIPUN GMS is a gastric motility monitoring system, by comparing its ability to assess gastric motility to manometry, a gold standard comparator.
‘The investigation is a part of the clinical program evaluating the safety and efficacy of the VIPUN Gastric Monitoring System. We are convinced that the VIPUN GMS has the potential to significantly change the way clinicians monitor gastric motility and provide enteral nutrition.’ said Pieter Janssen, VIPUN Medical CTO. ‘We look forward to execute our further plans for clinical validation of the VIPUN GMS, and offer the potential to directly enhance care, especially in critically ill patients.’
About VIPUN Medical
VIPUN Medical is a privately-owned clinical stage medical device company, pioneering a novel method of gastro-intestinal monitoring aimed at enhancing medical nutrition for critically ill and other vulnerable patients. The VIPUN Gastric Monitoring System aims to make it easy for medical staff to make a well-informed and faster nutrition therapy decision thus reducing malnutrition and feeding-related complications. VIPUN Medical is located in Mechelen, Belgium. Visit www.vipunmedical.com for more information.