Policy on the Appropriate Use of Fabtech Materials in Medical Device Manufacturing

Fabtech Systems seeks business relationships with customers who actively participate in and contribute to the Orthotics and Prosthetics healthcare industry. Fabtech Systems' core principles that guide its behavior with respect to the use of its products in medical device application are provided in this Appropriate Use Policy. 

Definition of Medical Device Manufacturer 

For the purposes of this policy, the Medical Device Manufacturer is defined as the person, company, clinician, or other educated and certified individual responsible for fabricating, modifying, and delivering a medical device for patient use. This includes professionals with the requisite knowledge, skills, and certifications necessary to ensure proper application and functionality of the medical device. 

Responsibility of the Medical Device Manufacturer 

It is the sole responsibility of the Medical Device Manufacturer to determine the suitability of all new raw materials, products, and components, including any Fabtech products, to ensure that the final end-use product: 

1. Is safe for its intended use. 

1. Performs or functions as intended. 

1. Complies with all applicable legal and regulatory requirements. 

The Medical Device Manufacturer is solely responsible for: 

• Conducting all necessary tests and inspections. 

• Evaluating the medical device under actual end-use requirements. 

• Adequately advising and warning purchasers, users, and/or learned intermediaries (such as Orthotic/Prosthetic professionals) of pertinent risks. 

• Fulfilling any postmarket surveillance obligations. 

Any decision regarding the appropriateness of a particular Fabtech material in a specific medical device must be based on the judgment of the Medical Device Manufacturer, seller, competent authority, and treating professional. 

Warranties 

FABTECH SYSTEMS WILL NOT WARRANT THAT ITS PRODUCTS ARE SUITABLE FOR USE IN ANY MEDICAL DEVICE OR MEDICAL APPLICATION. 

Adhesive Products Compliance And Liability Disclaimer

Warning: Adhesives are not intended to function as a standalone structural component. They are specifically designed for use as a filler material to be fully encapsulated by an external permanent structural layer—such as carbon fiber composite or thermoplastic—during device fabrication.

Use outside of these parameters may compromise device performance. The practitioner/technician is solely responsible for verifying the suitability, application technique, and final outcome of the device.