Overview & Regulatory Context higi SH LLC (higi) is a certified Quality Management System and Medical Device Standards (ISO 13485) company. It complies with all regulations associated with the design, manufacturing and distribution of health monitoring tools. In addition to ISO certification, higi medical device products receive FDA clearance (via the 510k process) prior to market introduction in the USA. To view our Accuracy Statement click here.
- higi experiencing exponential growth
- higi Launches New Partnership Initiative with National Brands, Thought-Leaders and Celebrities
- Virtual health challenges with gamification can drive behavior change and may lower blood pressure
- higi to put health kiosks in Shopko stores in 18 states
- higi Announces New Partnership with Shopko Stores