We are committed to delivering high quality products with outstanding value built on the foundation of a dynamic goal-oriented quality management system. Our continual investment in quality ensures that we exceed the expectations of our shareholders, customers, partners, key stakeholders, and employees.

Our quality management system is ISO 13485:2016 certified, compliant with the United States Food and Drug Administration’s current Good Manufacturing Practices (cGMP: Quality System Regulation Part 820 of CFR Title 21, Volume 8), European Union’s Directive 98/79/EC on in vitro diagnostic medical devices (transitioning our QMSto the IVDR 2017/746 is in progress), and Health Canada Medical Device Regulations (SOR/98-282).

Additionally, we adhere to ISO 14971 (Application of Risk Management to Medical Devices) and ISO 2859 (Sampling Procedures for Inspection by Attributes). Certification and compliance to these requirements attests to our ability to maintain the highest standard of quality in medical device manufacturing, product development and corporate conduct.