Quality and Compliance Information

At Sight Diagnostics® we place the highest value on quality. As such, quality is an essential part of Sight’s goals and processes.

Sight’s Quality Management System policies define our arrangements for managing operations and activities across all disciplines and at all levels within the company in accordance with the framework established by the FDA Quality System Regulation (21 CFR Part 820) and ISO 13485. Sight has also been certified by the Medical Device Single Audit Program (MDSAP).

Sight OLO is FDA 510(k) cleared. Our Regulatory Affairs department manages registrations and listings with the FDA and all other regulatory authorities in territories in which Sight holds business.

To learn more about our regulatory and compliance approach, please refer to the information below: