OUR QUALITY COMMITMENT
Exceptional Quality and Unparalleled Service
We design, manufacture, and deliver innovative medical devices with the objective of positively impacting the health and well-being of patients around the world. Given the nature of these products, quality is of paramount importance in the culture and operation of our organization.
What We Do
We have established a Quality Management System utilizing Greenlight Guru in compliance with ISO 13485, FDA 21 CFR Part 820 and other appropriate national regulations to guide our actions and ensure safe and effective devices. We are committed to establishing a quality culture and providing quality products by:- Producing innovative and reliable medical devices and components that add value to the life science industry via a needs-based approach;
- Providing unparalleled service to our customers;
- Establishing and continually improving our Quality Management System; and,
- Establishing and regularly reviewing quality objectives.
Our Facilities
Our production site is located in Cleveland, Ohio, and is designed with designated areas for wet processing, lyophilization, mix & fill, packaging, and temperature-controlled storage.
Extracellular Matrix
Biomaterials
Medical
Applications
Design
Services
Contract
Manufacturing