
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.