Medical device companies look to RBC for our Advanced Manufacturing Services in cases where we developed the device and when our team can deliver value over doing manufacturing inhouse.
RBC is an ISO 13485 | ISO 9001 certified, FDA registered Medical Device manufacuturer. With decades of combined experience in medical device engineering and contract manufacturing, our team knows what it takes to produce high quality equipment and deliver it on time. We specialize in the manufacturing of Class I, II, and III medical devices for US and International markets.
Medical device innovators who choose RBC as their medical device engineering and contract manufacturing partner say they selected us for these reasons.
1. Quality. We have stringent processes for documentation, GMP diligence, training, and regulatory processes as required in this highly regulated industry.
2. Complexity. RBC specializes in the manufacture and assembly of complex electromechanical medical devices. We have been in the field for 22 years and likely have immediately relevant experience to lend to your project.
3. Low run volume. We are set up to also handle smaller runs and therefore do not require the large volume commitments other manufacturers do.
4. Development support. Our engineering teams supports the changes required through the product’s life cycle.
5. Location. RBC Manufacturing is located in the United States, at our centrally located facility in Lenexa, Kansas.
Look to RBC for:
• Device, Sub-Assembly or Accessory Production
• Device Testing Services
• Device Servicing and Repair
• Manufacturing Engineering Support
• Manufacturing Process Development and Fixture Design
• Energy-based Product Manufacturing Expertise
• Material Sourcing and Procurement Services
• Logistical Warehousing and Fulfillment Services
• Full Product Lifecycle Support
• Transfer of Existing Product Lines
Contact us to learn more about our complex medical device engineering and contract manufacturing.
510(K), PMA, AND CE MARK SUBMISSIONS
Depending on your needs, RBC Medical Innovations can produce all or part of the design documentation required for a FDA 510(k) submission, pre-market approval, or a CE Mark technical file.