Project Feasibility & Planning

The highest quality innovative solutions on time and budget

Effective medical device design and development starts with understanding your needs and preparing a thorough project analysis and plan.

RBC can help you – on target, on time, and on budget.

Medical device project management and design starts with structure but also many questions.

Medical Device Design & Development Services

What is the intended use of the medical device?
What intellectual property and technology is available for this medical device innovation?
What do market, user, and patient experience say about the problem you seek to solve with your medical device?
What are business and design risk factors?
What are the regulatory considerations?
Is there a predicate device and a path for FDA 510(k) clearance? Will we seek CE mark certification?
What prototypes (preliminary or otherwise) will be needed for marketing, clinical, engineering, certification and other purposes?
Are there any special supply/sourcing considerations?
What are the estimated volumes for manufacturing?
Most importantly, how will you define project success?

Get In Touch with RBC

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Years of Experience

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Largest Medical Device Companies Trust RBC

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of Customers Do Repeat Business

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Average Project Timeline Acceleration

“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!”

Among the designs we actively support:

RBC Medical Innovations will assist you from concept to commercialization

Of course, these questions are just the start of the medical device project management process. Then we cover a full “Procedures Checklist” of 36 major strategic and design considerations. With this clarity, you can be sure RBC has the insights and tools necessary for your success.

RBC Medical Innovations will assist you from concept to commercialization, including manufacturing in small lots by hand right here in the United States. Our portfolio ranges from critical care ventilators to handheld glucometers to RF ablation systems to new initiatives for start ups and more.

RBC Medical Innovations is ISO 13485 | ISO 9001 certified and FDA registered, with 26 years of experience supporting contract medical device design, development, and manufacturing.

Whatever your medical device design and development project, we have a full complement of program managers, systems engineers, interaction designers, mechanical engineers, software engineers, and electrical engineers to kick off your project with a complete view of the opportunities and obstacles that lie ahead on the path to your launch.

Do you have the available resources and capabilities to transform your product development vision into a commercial medical device?

We focus exclusively on producing Class I, II, and III medical devices for FDA PMA or 510(k) clearance as well as international CE marking. Our clients partner with us in medical device project management and consulting because we have accomplishments that demonstrate we have the tools, resources, certifications, expertise and networks of help to transform their vision into reality.

A Comprehensive Portfolio of Success

RBC Medical has 25+ years experience designing, developing and manufacturing a broad range of complex medical devices.

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

Pulsed Field Ablation

Nerve Tissue RF Ablation System

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.

Project Feasibility & Planning

Effective medical device design and development starts with understanding your needs and preparing a thorough project analysis and plan.

Medical Device Design & Development Services

Get In Touch with RBC

RBC Medical Innovations will assist you from concept to commercialization

RBC Medical Innovations is ISO 13485 | ISO 9001 certified and FDA registered, with 26 years of experience supporting contract medical device design, development, and manufacturing.

A Comprehensive Portfolio of Success

510(K), PMA, AND CE MARK SUBMISSIONS

Portfolio

Design & Development

RBC Medical

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