RxFIBER QUALITY SEAL

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MEDICAL GRADE FIBER - RxFIBER QUALITY SEAL

In the medical device industry, RxFiber understands the importance of reliable sources that provide high-quality products that will comply with FDA standards. This is especially true of fiber sources that medical device companies choose to use for their implantable devices. The RxFiber Certified Medical-Grade Fiber Quality Seal represents that our product has been manufactured under ISO13485 standards and tested under ASTM methods. Specifically, each spool of fiber manufactured by RxFiber is tested to ensure it meets strict industry standards and customer specifications, and has fully traceable quality systems behind it.

RxFiber products are produced in a controlled environment under rigorous quality guidelines that govern our development, manufacturing, testing, release and shipping. Each product receives a part number that undergoes a validation process to ensure quality consistency with each subsequent order. All raw materials included in each product maintain traceability through the life of the product and all records are maintained indefinitely. Additionally, each spool of product is individually identified, tested and labeled to ensure product quality and traceability.

 

Advantages:

  • The RxFiber Quality Seal represents testing requirements that exceed the common market standards.
  • RxFiber customers receive a signed certificate of conformance stating that the examined products have demonstrated good manufacturing practices (GMP) and comply with ISO 13485 standards and ASTM methods.
  • Physicians and patients will appreciate the investment in high-quality manufacturing and testing.