Case Study: Amnion Life achieves a strong, compliant eQMS foundation with Greenlight Guru

How Greenlight Guru Is Laying the Foundation for Success at Amnion Life

Amnion Life, a 2016-founded startup developing the AmnioBed (a novel Class II device pursuing a De Novo pathway), faced the common early-stage challenge of limited in-house medical device quality and regulatory expertise. The team had been juggling spreadsheets and multiple platforms without true design control support and sought an eQMS vendor that would act as a partner—ultimately selecting Greenlight Guru’s eQMS and Guru Services to establish a compliant, scalable quality foundation.

Greenlight Guru delivered an out-of-the-box, medical device–specific eQMS plus dedicated Guru Services, providing prebuilt workflows, integrated design control and risk management, and hands-on guidance during implementation. As a result, Amnion Life streamlined processes, eliminated tedious manual design-control paperwork, improved documentation for their Design History File, gained confidence and “peace of mind,” and accelerated product development as they move toward clinical trials and post‑market stages with Greenlight Guru as an ongoing partner.

Amnion Life

Amir Fassihi

M.D., Fouender and Chief Executive Officr