RBC Medical Innovations is ISO 13485 | ISO 9001 certified, FDA registered and audited, and have been supporting the design, development and contract manufacturing of FDA 510(k) and PMA medical devices since 1994. We partner with clients worldwide, including 7 of the top 20 medical device companies as well as established and start-up organizations who will be future industry leaders. When you entrust your vision to us, you get these commitments in return – RBC Medical Innovations will design, develop, test, and produce the customized solution to transform your vision into a commercial device that is delivered to market on target, on time, and on budget.
Medical Device Design and Development Services
RBC Medical Innovations focuses exclusively on designing and developing Class I, II, and III medical devices for US FDA 510(k) or PMA and international agency approval. We have the tools, resources, and experience you need to lead the design and development of your device or expertly fill in the gaps where you need additional support for your project team. Our turnkey, team augmentation, or business development services are supported with an integrated and disciplined project management, quality/regulatory management and assurance process.
|
|
Medical Device Contract Manufacturing
RBC Medical Innovations is an FDA registered and audited medical device contract manufacturer. We are a ISO 13485:2012 and ISO 9001:2008 certified and 21 CFR 820 compliant partner, who approaches quality management as a continuous improvement and customer satisfaction process. We specialize in providing quick-turn prototyping and commercial production solutions with unmatched electromechanical device expertise. We also offer the additional flexibility of integrating engineering services around your device maintenance and lifecycle development needs. Simply put, you choose how to engage our capabilities and we will build a custom solution to support your vision.
Embedded Software and Device Connectivity Expertise
Given the growing dependence of medical devices on software and wireless communication, as well as the strong correlation between software complexity and potential for defects, RBC has developed a custom software design and development process that focuses on supporting IEC 62304 standards and the FDA’s concern for life sustaining Class III devices. Our software engineers are experienced in all aspects of embedded software development – from the simple (micro-power, 8-bit designs using Assembly and ANSI C) to the complex (30+ MIPS, ARM, DSP X86-based multiprocessor systems using the off-the-shelf or custom RTOs).
We are a member of the iOS Developer and MFi Developer Programs and licensed to develop electronic accessories and software applications designed for use with the iPhone®, iPad® or iPod®. Our unique advantage of applying twenty years of experience in developing FDA approved electro-mechanical devices utilizing embedded software, along with our expertise of integrating Bluetooth® technology, ensures successful development of home use medical devices for distribution on the App Storesm.
AdvantageRF
RBC Medical Innovations is also the distributor of choice for the revolutionary AdvantageRF Development Platform - a medical Radio Frequency Generator (RFG) that is flexible, powerful and easy to use, with energy profiles and parameters that are fully customizable at the touch of a button! So whether your new device will be used for ablation, cutting, coagulation, cauterization or other procedures or treatments, AdvantageRF helps you immediately begin development of your delivery devices and custom energy delivery profiles. Commercialization that used to take years can now be realized in months!
Contact us today to transform your vision into a commercial medical device that is on target, on time, and on budget.