Source：The Insides Company Limited
On：15 December 2023
Organisation：The Insides Company Limited
The Insides Company is pleased to announce that The Insides® System and The Insides® Neo have received CE Mark certification under the new European Union Medical Device Regulation (EU MDR).
EU MDR is an important certification for The Insides Company’s products. It provides independent verification of the company’s commitment to and compliance with European market regulations for quality management, manufacturing, and product quality control.
Garth Sutherland, the CEO of The Inside Company, stated, "The attainment of this certification reflects our proactive adjustment to the latest and rigorous regulatory standards in Europe. This certification provides ongoing access to The Insides System for adults experiencing severe intestinal failure, and marks the new availability of The Insides Neo for infants facing an intestinal catastrophe.”
About The Insides Company
The Insides Company is a leading provider of purpose-built chyme reinfusion therapeutic medical devices for severe intestinal failure.
CEO, The Insides Company
Phone：+64 9887 9309