Source: The Insides Company Limited
On: Friday, 31 January 2020 – Auckland
The Insides Company has received ISO 13485 certification and CE mark approval for its chyme reinfusion therapeutic medical device solution. These certifications and approvals mean the device is now cleared for marketing in Europe and the United Kingdom.
The Insides Company received the ISO 13485 certification following an audit by TÜV SÜD. ISO 13485 certification is an internationally recognized quality management system standard in 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 severe gut disease, including enterocutaneous fistula. Restoring bowel continuity through chyme reinfusion enables patients to begin oral nutrition again. Oral nutrition, as opposed to parental nutrition, reduces the risk of infection, dehydration, kidney and liver damage, and reduces the time to surgical closure.
Garth Sutherland, CEO of The Insides Company, said: “these are important milestones for intestinal failure centres, their patients, and our company”.