Discover High-Mix Manufacturing Built for Medical Devices
Partner with one of the only single source, U.S.- based medical device manufacturers that delivers scalable, adaptable, and cost-effective production.
Leverage Innovation to Get Your Product to the Point
From small-scale contract manufacturing to blue-chip OEM production, Ranfac oversees every step of the development process with quality, engineering, manufacturing, and supply chain housed under one roof. Schedule a demo to discover how our nationally-recognized facility can help your organization:
Expedite device production and launch
Develop strategic cost management plans
Streamline regulatory clearances with in-house filing
Scale production volumes to meet customer demand
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Machining
Ranfac’s Machine Shop remains on the cutting edge of innovation and automation, leveraging robotics integration to increase scale and maximize efficiency. Our capabilities include cutting, grinding points, laser welding, and preparing steel for over-molding.
Molding
Our Class 8 clean room environment delivers both over-molding (insert molding) and injection molding. To meet the unique needs of each customer, we offer numerous standard mold tools, including luer lock, stylet, and cannula handles. We utilize Battenfelds and Arburgs alongside automation to increase capacity and accuracy.
Finishing
Our ultrasonic cleaning methods use common types of acidic, neutral, and alkaline cleaners along with neutralizers and triple cascading deionized water rinsing and heated HEPA filtered dryers. We offer descaling and passivation to bolster the formation of Chromium Oxide on stainless steel and to remove manufacturing process oxides.
Assembly
Ranfac’s Class 7 clean room was designed for high-mix production assembly, supporting a diverse range of jobs in one room. Our mobile barcode scanning system links directly to our ERP system for real-time insights into the workflow of the manufacturing process.
Sterilization & Packaging
We guarantee finalized sterile products by managing the entire ethylene oxide (EO) sterilization process, including all requisite testing and validations. Our team oversees all elements from assembly to final packing with thorough inspection and documentation. Once sterile, our products are validated and packed accurately to customer specifications.
Warehousing
Ranfac’s utilization of satellite warehouses throughout the facility brings our products to the point of use, increasing both speed and accuracy. We proactively organize products based on usage to streamline handling and guarantee delivery. Moreover, Scanco Warehouse 100 houses records of all items and is easily accessible.
Proven Commitment to Quality & Compliance
Ranfac’s legacy is based on a deep commitment to maintaining compliance with the highest level of quality standards. Our in-house quality team handles all regulatory submissions to guarantee every single device we produce is fully compliant and consistently meets patient and user needs. As a certified medical device manufacturer, Ranfac has received the following regulatory certifications:
MDR
MDSAP
ISO 13485:2016
EU Quality Management System
FDA
CGMP/QSR
COMPANIES THAT TRUST US
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“Ranfac was the first group—and really only group—that we approached, because I knew that they had an unparalleled reputation for putting out a very high-quality product and also they have a completely integrated facility there…They are recognized as being the best at their particular specialty.”
ANDREW MCGILLICUDDY
CEO, Endocellutions
