We put quality first in everything we do.
As a legal manufacturer of sterile medical devices we are required to comply with the requirements of the FDA's 21CFR 820, as well as ISO 13485. These quality standards are the foundation of our quality management system and services, ensuring defect prevention, continuous improvement, and reduction of waste and variation in the supply chain, finally helping us to deliver exceptional products that meet or exceed the requirements of customers and regulatory agencies around the world.
In response to regulatory requirements, we utilize non-hazardous materials which comply with REACH & RoHS directives. To be successful in our goal, we also request the support and cooperation of our entire supply chain providing materials, critical components, assemblies and/or services. If there is ever any question as to whether or not a potential change may impact the quality of a finished device, we should have prior written notification and where appropriate, approval from our client.