RK Manufacturing can be contracted to produce medical devices that require manufacture, assembly, testing, and packaging in a clean room environment. We have certified sterilization sub-contractors to bring your product to operating room levels of sterilization. Our Quality Management System has been certified to ISO 13485 to ensure quality products are made by current Good Manufacturing Practices (cGMP).Our Capabilities
Our engineers ensure your success from product inception, providing design reviews and realistic input.
A 15,000 sq. ft. clean room allows us to quickly and efficiently compartmentalize your product.
Your project doesn’t end with production—we can provide assembly and final packaging solutions.
We’ll manage your material needs, factoring in quality, growth spikes, and shelf life. Transparency and communication ensure we’re always on the same page.
We work with many suppliers to ensure your project’s raw materials have quick turn-around and reasonable MOQ, allowing you to make informed decisions.
We are constantly expanding our footprint, our in-house service offerings, and our selection of project-specific equipment and validations.