Most RBC clients engage us to service their products long after the medical device design, product development, and manufacturing transfer stages are complete.
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:
- State the opportunity. State what must be done, not how to do it. 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.
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 medical device 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.
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. Just let us know – Would you like to handle agency submissions on your own or with our help?
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.