About Us

The IVD Assay Development & Manufacturing Experts

The teams behind Fortis Diagnostics have been quietly doing the work since 2008 when they were founded as IPOC and Empirical Biosciences (2011). Fortis reagents (both lyophilized and wet) form the foundations in numerous diagnostic, research, and cosmetic kits under separate brands (OEM). The teams specialize in enzyme and formulation development, assay enhancement, kitting and packaging, and lyophilization of reagents into beads. IVD assay development is our speciality. 

IVD assay development and manufacturing facilities are located in Grand Rapids, Michigan, and Toronto, Canada, providing the ability to manufacture in both the United States and Canada while supporting regulatory compliance for customers serving markets around the world. With over 70K sq.ft. of manufacturing space, our suites include: 5,000 sq.ft. low humidity environmental rooms, negative pressure isolation labs, bacterial fermentation, FPLC purification, reagent formulation, freezer farms, and kitting.

Quality forms the bedrock of Fortis Diagnostics, with a Quality Management System that is maintained to ISO 13485 standards. We have had strong utcomes over two decades of certification audits. The QMS supports regulatory expectations applicable to GMP manufacturing for medical devices.

Working at Fortis Life Sciences

If helping others succeed and advancing medical sciences drives you, consider joining our team. As a member of our staff, you will enjoy the friendly and collaborative atmosphere, while being challenged with provocative projects that positively impact the lives of patients. Manufacturing support roles offer flexible schedules, while in R&D you will be working with top-tier equipment, reagents, and collaborating with some of best minds in the medical device industry.