Manufacturers of Medical Devices must ensure they meet all national standards for safety and compliance in the country they wish to market their products. Different national legislative bodies such as the FDA, MHRA, TPD and European Commission all are united in their goals for the utmost in patient care and benefit, but they are not harmonized, meaning a product has to go through an approval process for each legislative body separately.
To support our customers in these different markets we maintain clean room manufacturing operations where the highest procedural levels of cleanliness are observed and validated to ensure ongoing compliance. All our components are assembled into medical devices prior to sterilization.
As early as 1902, Senior Flexonics, then known as “Chicago Tubing & Braiding Co.”, was closely tied to medical devices, specifically for the dental industry by developing a process to braid rubber tubing with silk and cotton yarn.
From this 100 year legacy, we understand that the manufacturer of a medical device has unique needs that are critical when the product is reviewed. As part of our accomplishments, we have worked closely with our customers to develop components used in medical procedures such as bypass surgery, cardiovascular ablation and endoscopic surgery by providing them with various products including flexible metal tubing, medical grade cooling coils, and custom heat exchangers.
- Bypass Surgery
- Cardiovascular Ablation
- Custom Heat Exchangers
- Flexible Metal Tubing
- Medical Grade Cooling Coils