Systems Engineering & Support

Leverage our expertise to ensure the success of your project

Medical Systems Engineering at RBC follows a familiar and iterative path

The medical device systems engineering process determines the outcomes to be produced, identifies the most probable or highest risks, and finds effective and efficient solutions to produce the outcomes. With our industry standard approach to Systems Engineering, seasoned medical device engineers will be talking about product development with people just like them.

Medical Device Systems Engineering at RBC follows a familiar and iterative path:

Understand the goal: Captures customer requirements with inputs from end users, operators, buyers, regulatory agencies, manufacturers and other key stakeholders.

Investigate alternatives: Derives multiple ways to achieve compliance relative to requirements. Minimizes project risk.

Model the system: Prototyping and running process models to understand efficiencies, reduce costs, and manage risks.

Integrate: Ensures the device will work within a larger system and other finished products.

Launch: Validation and verification ensures the system do what it is intended to do.

Assess Performance: Measurement is key so RBC captures quantifiable data and technical performance to optimize the process.

Reevaluate: Observe outputs and use information to modify the system, inputs, process, or product.

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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!”

Our medical engineers will focus on exceeding your expectations

RBC determines and tags medical product requirements upfront

RBC’s senior systems, quality, and regulatory experts determine and tag product requirements up front. This allows us to fully trace all requirements into testing, resulting in a quality product, predictable development costs, and a designed delivery methodology that meets or exceeds your expectations.

At the systems engineering stage, RBC will identify the relevant performance and safety standards for product development. The resulting requirements will drive the product design to meet applicable test requirements during certification. This is a proven strategy for RBC and our clients. And since we consult with regulatory agencies (UL, CSA) and their representatives early in the product development process, you’re ensured expedient approvals.

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.

Systems Engineering & Support

Medical Systems Engineering at RBC follows a familiar and iterative path

Get In Touch with RBC

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

510(K), PMA, AND CE MARK SUBMISSIONS

Portfolio

Design & Development

RBC Medical

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