Systems Engineering & Support

Leverage our expertise to ensure the success of your project
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.

Get In Touch with RBC
0 +
Years of Experience
0 /10
Largest Medical Device Companies Trust RBC
> 0 %
of Customers Do Repeat Business
0 %
Average Project Timeline Acceleration
Our experts will focus on exceeding your expectations
RBC Medical_day_01142960210jpg
RBC determines and tags 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

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.