Medical Device Qualified Supplier Directory
Qualifications: ISO 13485, ISO 9001, Supplier to Medical Manufacturers
Markets Supplied: Worldwide
Banner Medical Innovations, part of the Banner family of companies, is proud to be serve the Medical Device community. Since 1961, we have served the precision machining industry by providing the highest quality materials and value-added services that offer superior processing capability, reduced supply chain complexity, and risk mitigation. As an ISO 13485 certified supplier to the medical device industry, Banner Medical Innovations has implemented stringent quality standards and employs talented personnel who have thoroughly validated our equipment and practices through the IQ, OQ, and PQ processes required by FDA protocol. Few processors of medical grade material perform validation testing to this degree. Our mission is to provide defect-free materials and components that allow our customers to manufacture the best products for the medical device industry.
Our strategic relationships with producing mills and our in-house service capabilities allow us to source and process medical grade material to near-net shapes, making us the one stop shop for medical implant and instrument manufacturers globally.
Non-Destructive Testing – Ultrasonic (UT) Immersion
- Water-jet Cutting
- Material Identification (Niton Gun)
- Precision Cut-to-Length
- Line Marking
- Heat Treating and Stress Relieving
- Near-Net Shaped Components and Implants
- Centerless Grinding
- Small-Run and Production-Run Machining
- 510k Support/FDA Compliance
- Material Traceability
- Rapid Prototyping Services
All of our processing equipment and manufacturing practices have been subjected to IQ, OQ, and PQ validation.
Another key element in our Quality Management System is the ability to maintain all pertinent documentation regarding material traceability. Per FDA 820.60, FDA 820.65, ISO 13485, and ISO 14971, all manufacturers must maintain raw material traceability throughout the supply chain and production process. We have built-in protocol to assure traceability to melt source as part of the incoming inspection process for all materials received. We can also supply and maintain traceability information in standardized or custom form as part of the Device History Record for any OEM or Contract Manufacturer we serve.
Quick Response Manufacturing (QRM) is a University of Wisconsin-Madison-based program that helps companies with low-volume, high-variability or custom-engineered products reduce their lead times in the marketplace. Banner adopted the QRM methodology in January 2014 and has been able to reduce lead times by 50% in quoting, order entry, production, and shipping.
For more information contact Banner Medical Innovations