High-mix Medical Device Manufacturing Company for Specialized Applications
Get to Market and Scale With Reliability and Repeatability
Ranfac’s focus on Class I and II single use devices, combined with over a century of experience, provides a unique relationship to our customers. No matter the size of your company or the scope of your project, you can take advantage of Ranfac’s highly automated, flexible manufacturing platform, which allows us to scale production volumes from the needs of a small startup to the demands of a blue-chip OEM. Our Avon, MA facility houses full source capabilities through each stage of production—from the machining of raw materials through the assembly and packaging of sterile product. Having full in-house control over the operation assures the quality and efficiency that your product requires.
Original Equipment Manufacturing (OEM)
As a leading original equipment manufacturer for medical devices, Ranfac leverages a ground-up approach to efficiency, compliance, and quality to plan upfront for enhanced downstream scalability. Learn more about how our proprietary 4-step model can help you drive successful product launches.
Medical Device Contract Manufacturing
Whether your business is a startup looking for small-scale product volumes or long-term manufacturing support, Ranfac is here to meet your needs with flexible and scalable production that adheres to the most stringent medical device manufacturing regulations.
Our Proven Medical Device Manufacturing Process
All new projects begin with a sit-down with Ranfac’s senior leadership. Here, we can get to know each other and determine if there is mutual interest in partnering. By having a clear understanding of your needs, we will determine the best solutions to get your product to market as efficiently as possible. Every device has its own unique challenges. That’s why Ranfac does not operate under a one-size-fits-all model.
Once we understand the scope of your project, we will build out a project plan broken down into our 4-phase development process, detailing expected development timelines, estimated costs for tooling, engineering and regulatory submissions.
With the plan approved, your dedicated project manager will be assigned as your partner from design through launch to manage your design history file (DHF) and will work closely with Ranfac’s production and quality teams to ensure your device is designed for ultimate efficiency and consistent efficacy.
Ranfac will compile documentation packages and other relevant paperwork to make your regulatory filing go smoothly. Ranfac can work on your behalf with the FDA and other international regulatory bodies to submit for applicable regulatory clearances. Note that Class I devices do not require FDA submission although they do require the same level of documentation and testing as a Class II device.
Once the Alpha phase has been reached and the product has been released to manufacturing, Ranfac will launch at your pace. We understand it takes time to get a new product off the ground, which is why we offer low minimum order quantities.
We look forward to growing together, which is why we are constantly reinvesting in our infrastructure and technologies to stay ahead of future demand.
Ready to Start?
Get in touch with one of our medical manufacturing experts to start the manufacturing process today.
Machining
Consistently growing and improving to provide for our customers’ needs, our Machine Shop’s core capabilities include cutting, grinding points, laser welding, and preparing steel for over-molding. We are constantly on the forefront of technological innovation, evidenced by our array of automated equipment and creative integration of robotics to increase scale and efficiency,
Molding
Operating out of a Class 8 clean room environment, we offer both over-molding (also known as insert molding) and injection molding. Customers can take advantage of many standard mold tools, including luer lock, stylet, and cannula handles or work with Ranfac on a custom tooling project. We leverage Battenfelds and Arburgs alongside automation to maximize capacity and accuracy while reducing the cost and time to develop a new product.
Finishing
Ranfac employs ultrasonic cleaning methods using 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 Chromium Oxide formation on stainless steel and to remove manufacturing process oxides. We clean assemblies and mitigate risks of entrapped spaces that lead to unwanted residues.
Assembly
Ranfac’s Class 7 cleanroom for assembly offers a controlled environment for preparing products for sterilization. Built for high-mix production, our assembly room can quickly switch between diverse types of jobs. We use a mobile barcode scanning system that links directly to our ERP system and allows for real-time insights into the workflow of the manufacturing process.
Sterilization & Packaging
Ranfac guarantees finalized sterile product by managing the entire ethylene oxide (EO) sterilization process, including all requisite testing and validations. We oversee all elements from assembly to final packaging with thorough inspection and documentation. Once sterile, Ranfac transports products back to our facility for validation and packaging according to customer specifications, utilizing a wide range of packing methods to ensure product integrity.
Warehousing
Ranfac’s satellite warehouses located throughout our facility bring products to the point of use with enhanced speed and accuracy. We streamline warehousing and handling by proactively organizing products based on usage. Furthermore, Scanco Warehouse 100 keeps a comprehensive record of all our items on a centralized, easily accessible platform. With all products documented and sorted, we guarantee efficient and accurate storage and delivery of your products.
Customer Success
Explore our case studies to learn more about how Ranfac provides peace of mind around manufacturing medical devices, meeting every customer need with top-tier, cost-effective, and vertically integrated solutions.
Testimonials
