Medical device approval and certification for Eli's first product


Hormones drive many of the conditions and transitions that women experience throughout their lives. Yet hormones remain a black box. Eli unlocks that box with a device that measures daily hormone levels at home, giving women the ability to take control of their health from puberty to menopause. This includes contraception, fertility, the transition to menopause and many conditions that uniquely or disproportionately affect women. The correlation between daily hormone levels and resulting health conditions is not yet available to women and the clinical and medical research community. This data is being made available for the very first time and it opens up many opportunities at the commercial, medical and scientific levels. The project aims to achieve Health Canada and FDA approvals for certification as a Class II medical device, as well as ISO 13485 certification which is a prerequisite for this approval. The benefits of this project for Eli, the industrial partner, are very important. This certification is a mandatory step for the commercialization of the company’s first product in Canada and the United States. The commercialization of this product will generate sales revenues and allow the company to close a very significant round of venture capital funding to accelerate its growth. Eli’s growth will also bring many positive impacts for Quebec.