The Insides Company is pleased to announce that The Insides™ Systemfi, a therapeutic solution for the management of the morbidities associated with enteroatmospheric fistulas and high output enterostomies, is now cleared for sale and commercially available in New Zealand.
This critical commercial milestone follows the completion of multiple certifications, including; IEC 60601 Certification for the safety and performance of medical electrical equipment; ISO 13485 certification for our quality management system; biocompatibility testing; and clinical validation.
The Insides Company has also completed the registration of its devices on Medsafe’s WAND (Web Assisted Notification of Devices) Database.
CEO Garth Sutherland said, “it is a fantastic milestone for an innovative company when it completes development of its first product and launches in its home market. My congratulations and thanks go to all the team and company’s founders on achieving this key milestone”.
About the Insides Company
The Insides Company Limited is a New Zealand-based medical device company, with headquarters located in Auckland. The company is a leading provider of therapeutic Chyme Reinfusion solutions for the management of High-Output Enteroatmospheric Fistulas and High-Output Ileostomies.