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RK Manufacturing: Redefining Quality for Next-Gen Medical Device Manufacturers

Steven M Hamilton, Business Development Manager

Manufacturing companies have long understood the fact that it takes more than just a scale to become successful. Quality, precision, and drive to be reliable often make the distinction between the ordinary and extraordinary, especially in the medical devices space, where precision needs to meet tight tolerance requirements. Having surpassed the test of time—with a vast range of experience and technical prowess—RK Manufacturing has adapted to the highest echelons of medical device manufacturing.

Founded by Ron Krebs, RK Manufacturing was at the cutting edge of suture processing equipment design and manufacture 42 years ago, a tradition of precision manufacturing that they have kept up with even today. The medical device manufacturing company is committed to providing high-quality products at competitive prices and building equipment for some of the industry’s largest OEMs.

Having started like many other great companies, in a small garage, RK Manufacturing soon grew and gained traction from suture manufacturers and OEMs for their manufacturing capabilities. Since then, RK Manufacturing has helped clients facilitate suture integration into devices and perform attaching work for OEM customers.

RK Manufacturing works hand-in-hand with their clients to ensure that each medical device will be manufactured, assembled, tested, and packaged in a state-of-the-art cleanroom environment, with all work monitored and documented for complete transparency. The company’s certified sub-contractors then brings the product to operating room levels of sterilization with absolute timeliness and auditability.

With 40 plus years of experience, RK Manufacturing can also help improve a client’s current suture production or assist them with the entire process from start-up through finished product. Thus, it must not be surprising that RK Manufacturing is the exclusive agent in the United States and Canada for one of the world’s largest suture needle manufacturers, Quality Needles (QN), Noida, India. The arrangement between RK and QN allows RK to supply companies bulk needles or integrate these needles with customer products as well as their own OEM’s. Unlike other suture needle manufacturers, QN offers all the popular needle configurations sold in the market today. QN also prides themselves in developing unique needles for Ortho/Endo/Lapro, and robotic surgery devices.

Furthermore, RK Manufacturing’s machine shop services provide precision custom tooling, fixture design assistance, in-house tool and die, prototype machining services, precision machined suture processing equipment, comprehensive machining services, CNC milling and turning for machined components, heat treating, grinding, welding and assembly and even worldwide shipping on all product types. Having a machine shop in house is a tremendous asset as the RK Machine Shop Team has created many unique fixtures, testing devices and other machining needs for customers.

RK Manufacturing is located in a newly renovated 68,000 sq. ft. facility featuring 13,500 sq. ft. of ISO Class 8 (100,000) cleanroom. RK is designed to move production into appropriate size areas to maintain proper flow and be able to separate products while being worked on simultaneously. RK is ISO 13485:2016 certified and FDA registered.

As a company, RK has grown a great deal and learned a great deal from the current pandemic with all the regulatory challenges brought forth by it. From the very beginning RK has adapted to all requirements by implementing procedures and policies. These implementations not only ensure the safety of all team members and products, but it also makes them one of the most sought-after medical device manufacturing partners in the market.

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Company
RK Manufacturing

Headquarters
Danbury, CT

Management
Steven M Hamilton, Business Development Manager

Description
Founded by Ron Krebs, RK Manufacturing is a medical device manufacturing company that is committed to providing high-quality products at competitive prices and building equipment for some of the industry’s largest OEMs. With 40 plus years of experience, RK Manufacturing can also help improve a client’s current suture production or assist them with the entire process from start-up through finished product. RK Manufacturing’s machine shop services provide precision custom tooling, fixture design assistance, in-house tool and die, prototype machining services, precision machined suture processing equipment, comprehensive machining services, CNC milling and turning for machined components, heat treating, grinding, welding and assembly and even worldwide shipping on all product types