PRODUCT DEFINITION
RBC Medical Innovations works to inject innovation into every new product – this is key to market success. But you need your medical device to succeed in a regulated market, which starts with quality and predictability.
RBC follows a requirements-driven process to accomplish product definition and architecture. Our 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 "no-surprises" design delivery.
REGULATORY & CERTIFICATION
RBC can identify the relevant performance and safety standards for your product. And, the resulting requirements become the drivers for the product design that meets the applicable test requirements during certification.. Our proven success strategy has us consult with agency (UL, CSA) representatives early in the product development process to ensure expedient approval.
On our own or supporting your regulatory staff, RBC Medical Innovations can produce all or part of the design documentation required for a FDA 510(k) submission or a CE Mark technical file.