ISO Certification

Because every product we make is used in medical diagnostics, Helena wants to ensure all of our products are safe and effective for the use intended. Toward that goal, we are pleased to announce Helena's ISO 13485:2016 certification.

Helena's ISO certification helps us meet Quality Management System requirements under USA, Canadian, and European regulations, while giving our customers a level of assurance that the processes we use to develop, manufacture and distribute products and services are reliable.