About Us

Banister Medical manufactures surgical instruments and orthopedic implants for world-class medical device companies. We specialize in manufacturing difficult, complex parts and assemblies to the highest dimensional, functional and aesthetic standards.

Contact Info

  • 3009 A.W. Grimes Blvd.
    Pflugerville, TX 78660
  • (512) 258-8351
  • info@banistertool.com
  • Weekdays: 8am to 5pm

Quality Systems


Years' Continuous Growth

Delivering Quality with Integrity

Our Quality Standards

Committed to Continually Improving our Processes

Quality and patient safety are always top-of-mind at Banister Medical. We take great pride in maintaining rigorous quality certifications and continuously improving our manufacturing processes to maintain the highest quality standards in the industry. We have been ISO 13485 certified for over 15 years, are registered as the manufacturer of record with the FDA for most of the products we make, and maintain an active license with the Texas Department of State Health Services. We are committed to continually reviewing and improving our processes, investing in new equipment and talent, exceeding our customers’ standards, and delivering safe, in-tolerance, great looking parts!

Banister Medical: big company capabilities, small company service.

Meeting & Exceeding Established Standards

Our Certifications

ISO Standards

  • ISO 13485 2016: Registered
  • ISO 10993: Biological Evaluation of Medical Devices
  • ISO 19227: Implants for Surgery–Cleanliness of Orthopedic Implants – General Requirement

EU MDR Compliant

The European Union Medical Device Regulation (EU MDR) was entered into application on May 26, 2021, wherein manufacturers, authorized representatives, importers, and distributors of medical devices in the EU, or a regulatory affairs or quality professional involved with medical devices must meet compliance guidelines.

Process Control

Materials & Cleaning Validation