RBC Medical Innovations is ISO 13485 | ISO 9001 certified, FDA registered and has been supporting the contract design, development, and manufacturing of medical devices since 1994. We focus exclusively on producing Class I, II, and III medical devices for FDA PMA or 510(k) clearance as well as international CE marking. When you entrust your vision to us, you get these commitments in return: we will design, develop, test, validate, verify and produce the customized solution to transform your vision into a device that is delivered to market on target, on time, and on budget.
We have the available resources and capabilities to bring your medical device vision into focus:
- Proof of Concept Prototyping
- Systems Engineering
- Electrical Engineering
- Software Development
- Mechanical Engineering
- Industrial Engineering
- Regulatory Requirements
- Quality Management
- Verification & Validation
- Human Factors Design
- RF Energy Expertise
- RoHS Compliance
- Project Management
Our Commitment to Fix Fee Pricing Offers Speed to Market and Less Risk – with RBC Medical Innovations, you benefit from our 20 years of expertise in medical product development and multidisciplinary approach. We will support your vision with a dedicated project manager and a systems engineer that will trace all requirements into testing – resulting in a quality product, predictable development costs, and a "no-surprises" design delivery and manufacturability. That is why we can commit to a fixed cost now - meaning no surprises for you later.
RBC Medical Innovations is a registered FDA contract manufacturer supporting the commercial production and servicing of complex electromechanical medical devices and life science products. Our facility is ISO 13485:2012 and ISO 9001:2008 certified and we are the ideal partner for custom manufacturing solutions – from prototyping, sub-assembly, device testing, to the transfer of existing manufacturing operations. Your vision will be managed by an interdisciplinary medical device engineering and production team, who will be supported with a diligent GMP compliant quality and regulatory documentation process to ensure success for your business objectives.
AdvantageRF™ supports immediate development of radio frequency energy-based treatment profiles and can shorten your time to market by at least 50%. AdvantageRF also enables you to launch updates, new patient connected devices and clinical treatments without touching deployed RFG!
Simply Plug-In to Engage Innovation – AdvantageRF is a portfolio of flexible mix and match solution tools for RF product developers that reduce risks, enhance reliability and sustainability, as well as accelerate time to market and lower R & D costs.
Engage us today to gain a competitive advantage through rapid commercialization and reduced risks for your non-invasive radio frequency medical device.
Embedded Software and Device Connectivity Solutions
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.
RBC Medical Innovations offers the available resources, capabilities, certifications and tools to design, develop, and manufacture your FDA PMA / 510(k) or CE marking product. Contact us today to learn how we can transform your vision into a commercial medical device that is on target, on time, and on budget.