Medical Device Contract Manufacturing

Experience process efficiency and high quality production that stands out among medical device contract manufacturers.

Flexible and Reliable Medical Device Contract Manufacturing

Get your new technology to market with speed and confidence by partnering with a trusted medical device contract manufacturer.

Why choose RBC for medical device contract manufacturing?

End-to-end design and manufacturing capabilities within a single company simplifies and expedites the entire process from concept to market.

Flexible manufacturing services that meet the needs of any sized company, from start-up firms to major high-volume OEM companies.

Confidence in high quality standards which is critical for the success of your product at launch and beyond.

Reduce production risks when you trust established and reliable processes for medical device manufacturing and supply chain management.

Minimize resource drain by working with an ISO 13485-certified partner with experience manufacturing thousands of FDA-registered and CE-marked medical devices.

Leverage smart, responsive support throughout the product lifecycle with our aftermarket services.

Get In Touch with RBC

Why Customers Choose Us for Professional Contract Medical Device Manufacturing

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Years of Experience in the Medical Device Contract Manufacturing Industry
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Largest Medical Device Companies Trust RBC
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of Customers Do Repeat Business
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On-time delivery for clients

Industry-Leading Medical Device OEMs Trust Us for Manufacturing

Our Proven Medical Device Manufacturing Processes

medical device contract manufacturer

Manufacturing Capabilities that Adapt to Your Evolving Needs

With more than 25 years of experience in medical device design and development, we’ve developed time-tested processes across all project phases that makes us stand out among competing medical device manufacturers. Let us help bring your device to market by navigating your new product through to commercial production.

We partner with some of the most innovative start-up firms, top 10 medical device companies and everyone in-between. 

Our experience as a contract manufacturer spans:

  • Pilot builds for preclinical or first in human use, as well as small and large batch commercial production
  • End-to-end design, development and manufacturing projects
  • Excellence in designing for manufacturability
  • Supplier and supply chain continuity management
  • Order management, distribution and warehousing
  • Capital servicing for internal and externally manufactured systems
  • Next generation evolution in regulatory, hardware and software upgrades.

Our medical device contract manufacturing services are specialized in complex medical device assembly. 

Our business model is flexible, with your needs in mind.

A Proven Design Transfer Approach Unique among Medical Device Contract Manufacturing Companies 

At RBC, we strive to ensure your time to market is accelerated and your design is ready for manufacturing as soon as possible. 

Our process engineers can be engaged upfront during the design phase. For other projects that may mean partnering to complete the last 10% that will drive your device into a cost-effective production plan. Whatever your project needs, we’ve got the in-house expertise necessary to bring your device to market. 

Get guaranteed compliance with all major regulations, including:

  • EN ISO 13485: 2016 certification by NSAI 
  • Based on FDA 21 CFR Part 820 regulations and Current Good Manufacturing Practices

Our specialization in medical devices sets us apart from other contract manufacturers, backed by our process and  systems, as well as electrical, software, mechanical and industrial engineers on staff. 

Work with highly skilled assemblers who are trained in building complex constructs and our test technicians’ expertise in new product and post-market testing. 

Let us handle the challenge of product manufacturing so you can focus energy and resources on running your business.

medical device contract manufacturing services
Medical Device Contract Manufacturing

End-to-End Project Management

Work with a manufacturer that is uniquely positioned to incorporate process engineering up-front. Our team approaches the project from all angles to guarantee success in design architecture, design manufacturability, and documentation, ensuring that the work is done properly the first time.

We identify potential gaps and assess supplier landscapes to manage long lead time components, actively mitigating threats to your supply chain. 

Work with industry-leading component manufacturers. Our staff is able to handle all your device design needs, whether it be injection-molded part design expertise or an expert manufacturer with deep knowledge of the life sciences sector, we have you covered.

When you sign a medical device contract manufacturing agreement  we guarantee you’ll work with an onsite process engineering team at our USA-based, Kansas manufacturing facility. That same team will provide support when moving your product design into assembly and testing. 

This concurrent design transfer approach can accelerate the manufacturing process before you lock down the design, validate, and engage in regulatory submissions. 

Flexible Manufacturing Operations for Small and Large Businesses

We are able to meet your production orders no matter the size. We partner to secure production schedules that align while providing strategic supply chain management. We have a proven record of 98% on-time delivery to our clients.

We are experts in efficiency, expediency and scalability for medical device manufacturing..

Our manufacturing capabilities for low-volume runs simplify production without straining your budget. And we’re ready and equipped to scale with the growth of your commercial needs. 

Medical Device Contract Manufacturing
Contract Medical Device Manufacturing

Complete Design Transfer to RBC

Our approach as your contract manufacturing partner starts with tried and tested Design Transfer processes. 

Our team is committed to bringing your product from design to an optimized manufacturing state. We leverage proven tools, processes and project management for seamless design transfer, employing contract manufacturing market best practices. 

We also integrate supply chain strategies early in the process. With complex devices, we plan for long lead components strategically and manage supplier relationships extremely closely. 

When your design is ready for production, our process engineers train and support the transition to our assembly and testing technicians.

Product Lifecycle Support

Our team provides invaluable insights throughout the entire life cycle of your medical products.

Beyond medical device manufacturing, our company specializes in consultations and product development support. 

We assist with everything you’ll need to bring your product to market and support commercialization, including:

  • Intellectual property research
  • Regulatory and certification restriction compliance
  • Supplier and supply chain management
  • Warehousing and shipping
  • Post-market servicing
  • Obsolescence management
  • Next generation product development
Medical Device Prototypes

Harness the Power of Our Manufacturing Processes

Our experts handle all of your developing and manufacturing needs.

A Proven Portfolio of Medical Device Success

We’ve used our professional manufacturing processes to bring thousands of medical devices and device components to market.

Spinal Tumor RF Ablation System

Invasive / Non Invasive Ventilator

Renal RF
Ablation System

Vascular Compression System

Intra-Aortic
Balloon Pump

Information
Management

Endoilluminator

Diagnostic Equipment

RF Puncture Generator

Bleed Monitoring system

Bleed Monitoring System

Pulsed Field Ablation

Pulsed Field Ablation

Nerve Tissue RF Ablation System

Trust Our ISO 13485 Certified Professionals for Your Medical Device Projects