Tekra has extensive experience and knowledge in servicing the medical diagnostic market and its unique film needs. This includes meeting FDA requirements such as lot control, traceability, inventory program management and large volume continuous supply. In addition, our medical team has many years of experience - use us as your consultants at any stage of your product developments and needs.
We can provide value as film consultants to the OEM's, as well as service and partnership support to the converter level. Our coating capabilities and fully staffed R&D lab can also be deployed to provide enhanced surface solutions for your particular application challenges.
Tekra Medical Plastic Film Applications
- Diagnostic Strips
- Transdermal Patches
- Face Shields
- Medical Labels
- Membrane Touch Switches
FDA Requirement Responsibilities
Tekra is a processor and supplier of film products to the medical diagnostic marketplace. As Tekra is not a medical device manufacturer, we are not subject to direct regulations by the U.S. Food and Drug Administration under the Federal Food, Drug and Cosmetic Act. However, as a key component supplier to the medical device manufacturers where it is applicable, Tekra follows FDA suggested cGMP guidelines and works in collaboration with our medical customers to identify characteristics of the film products and any Tekra operations that are critical to the successful operation of the finished medical device.
Tekra's exclusive supplier of polyester films, Dupont Teijin Films Americas, employs similar procedures when supporting a medical diagnostic application. While we cannot relieve our medical customers from their ultimate responsibility for determining a products fitness for use, we have extensive experience in product selection, design specifications, and supply chain management that will insure a successful implementation and outcome for any new diagnostic applications.