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

“My relationship with RBC spans three different companies and 15 years. I return to the RBC team because they consistently deliver innovative solutions in a timely and cost-effective manner. I plan to continue this relationship for many years to come!”

“RBC has provided us with a broad range of expertise, from electrical and software design to quality assurance and regulatory affairs. It would have been unlikely we could have hit our scheduled milestones without their help.”

We were a young start up with a great technology, but were running into issues that our manufacturing partner could not explain. Over a year later and still no clear solution, I engaged RBC to perform an independent analysis. Within 24 hours, they not only identified the issue, but also presented solutions to correct it. RBC came forward with the level of expertise that was necessary to help turn around the situation, allowing REACT to bring our advanced neuromuscular therapy to patients who need it.

“We were introduced to RBC during an acquisition. They were able to help define, develop proof-of-concept, prototype, fully develop, support in-vivo testing, certify, help gain regulatory approval and produce the first 100 units for a complex therapeutic device in less than two years. All of this in the midst of negotiating legal terms for the acquisition. I look forward to working with RBC on our next product!”

“We began our relationship with RBC for more than eight years to design and manufacture several radio frequency ablation medical devices. They have the staff, facilities and expertise to quickly produce the products we need, and the flexibility to respond to changes. I have counted on RBC to produce in several tough situations and they always come through.”

“I have worked with RBC on a complex electro-mechanical product and recommended them to several friends. As impressed as I am with their ability to quickly produce quality outputs, I am more impressed with how they handle unexpected situations. Anyone who knows medical device development knows there are always unexpected situations. I highly recommend anyone who is developing a new electronic product contact RBC.”

“We needed a firm with expertise in energy-based products and accessories. We approached RBC and found that not only did they have the expertise, but they had pre-made subsystems to accelerate and “de-risk” the program. I have since moved to a different part of the industry, but my former company continues to work with RBC to provide development and manufacturing services as well as subsystems. You cannot beat RBC for energy-based products!”

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.

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.

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.