Source: The Insides Company Ltd
On: 12:00PM, 31st January 2020
The Insides Company has received ISO13485 certification and CE mark approval for its chyme reinfusion therapeutic medical device solution, meaning it is now cleared for marketing in Europe and the UK.
The Insides Company received ISO 13485 certification following an audit by TÜV SÜD.ISO 13485 is an internationally recognized quality management system standard for the medical device industry.
TÜV SÜD also certified The Insides Company’s medical devices for intestinal chyme reinfusion to be in conformance with the European Medical Device Directive 93/42/EEC, thereby clearing these products for marketing in Europe and the UK.
The company’s medical devices significantly improve health outcomes in patients with serious gut disease including enterocutaneous fistula. By restoring patient bowel continuity, the chyme reinfusion platform enables the patient to begin oral nutrition again, thereby reducing the risk of infection, sepsis, dehydration, kidney and liver damage, and reducing the time to surgical closure.
Garth Sutherland, CEO of The Insides Company said “these are two important milestones for our company and for intestinal failure centres and their patients”.
About The Insides Company
The Insides Company Limited is a medical device company, spun out from the University of Auckland. The company’s transformative products reduce complications from gut surgery, accelerate recovery, and improve quality of life in patients with enterocutaneous fistula, colorectal cancer and IBD.