We're preparing to open our new medical device manufacturing facility. Our third facility, focused on medical device manufacturing, is under construction in North Carolina and will be operational within a few months. Our facility will be ISO 13485 certified and FDA registered. We offer Class I and Class II expertise and experience across a wide variety of product types. We have a large facility (190,000 sq. ft.) which provides a platform for rapid and seamless growth and capacity.
Our management team has decades of experience focused on medical device manufacturing, not only in injection molded plastics but in textiles and other materials as well.
We can assist in product design, 510k filing, regulatory compliance, validation protocols and application, and all areas that are specific to medical device manufacturing.
Kruger management has a successful track record of high quality and ISO / FDA compliant manufacturing. We have countless successful supplier audits, with experience working with the largest medical device OEM's in the market.
We go beyond simply manufacturing your products for you. We offer expertise and assistance from early product design stages all the way through final distribution logistics.
+/-50 injecting molding machines across two production facilities.
Robotics utilized to minimize labor costs and maximize efficiency.
Controlled molding temperatures through the use of chilled water and temperature control units.