ABOUT ADVANTAGE PLATFORMS DESIGN & DEVELOPMENT MANUFACTURING PORTFOLIO KNOWLEDGE CENTER CONTACT Medical Device Certification Project Support Remove the hassles associated with medical device certification. Keeping Medical Device Regulatory and Certification front of mind As we work together to bring your new product to market, RBC will help navigate regulation and certification hurdles. With greater than 25 years of experience in medical device design and development, our medical device regulatory consulting will assist you to: Ensure medical device regulatory compliance for all products you develop and bring to market. Minimize risk of certification complications by trusting our expertise in navigating global regulatory pathways including FDA, CE, UL, TUV and CSA. Streamline your new product regulatory strategy by implementing a comprehensive approach to certification.. Reduce time to market with safe and effective insights from our regulation and certification specialists. Expand upon regulatory clearances for your post-market device. Get In Touch with RBC Full Name* Email* Company Name Phone What Solutions Are You Looking For? Design and development Device Manufacturing Regulatory solutions Engineering support Software and Firmware Design Message Please verify your request* GET STARTED Medical Device Regulatory Support You Can Trust 0 + Years of Experience 0 /10 Largest Medical Device Companies Trust RBC > 0 % of Customers Do Repeat Business 0 % Average Project Timeline Acceleration Industry Leaders Choose RBC for Compliance with Medical Device Regulations “RBC has provided us with a broad range of expertise, from electrical and software design to quality assurance and regulatory affairs. It would have been unlikely we could have hit our scheduled milestones without their help.” CEO Katalyst Surgical Why Choose RBC for Medical Device Certification? Regulatory experience spans a broad portfolio Don’t let hardware limit your ability to operate the software you need. We have over two decades of experience developing both PC-based and embedded software development for medical devices. Trust our software engineers for your medical device embedded software development needs. Take advantage of our capabilities, which include: Simpler micro-power 8-bit designs using Assembly and ANSI C More complex 30+ MIPS, ARM, DSP, X86-based multiprocessor systems Off-the-shelf or custom RTOS We also specialize in PC-based software development: Fluent in all high-level platforms Create automated test fixtures Perform clinical data analysis Device software updates Trusted Certification Markers and Compliance Standards Throughout our design and development processes, we’ve built broad expertise and deep knowledge in what it takes to gain regulatory approval. Because we focus specifically on medical devices, we understand how to navigate Class I, II and III medical devices for FDA PMA or 510(k) as well as international CE marking. See examples of our work on the following cleared and on-market products: Spinal tumor RF ablation systems Invasive/non-invasive ventilators Renal RF ablation systems Intra-aortic balloon pumps Vascular compression systems Endoilluminators Intra-vitro diagnostic equipment RF puncture generators Information management systems NEED REGULATION AND CERTIFICATION ASSISTANCE? Contact RBC’s experts to discuss regulatory consulting for medical device rates! RBC CAN HELP Proven Success for Continued Innovation with Certainty RBC’s engineers help to simplify the certification process. Companies of all sizes trust us to help bring new medical devices to market. Spinal Tumor RF Ablation System View Product Invasive / Non Invasive Ventilator View Product Renal RF Ablation System View Product Vascular Compression System View Product Intra-Aortic Balloon Pump View Product Information Management View Product Endoilluminator View Product Diagnostic Equipment View Product RF Puncture Generator View Product Bleed Monitoring System View Product Pulsed Field Ablation View Product Nerve Tissue RF Ablation System View Product Medical Device Regulation and Certification Professionals 13715 W 109th Street Lenexa KS 66215 (855) 865-4711 Portfolio Spinal Tumor RF Ablation System Invasive/Non-Invasive Ventilator Renal RF Ablation System Intra-Aortic Balloon Pump Information Management Vascular Compression System Endoilluminator In-vitro Diagnostic Equipment RF Puncture Generator Pulsed Field Ablation Bleed Monitoring System Design & Development Fast2Market™ Process Project Feasibility & Planning Proof of Concept & Prototyping Systems Engineering & Support Electrical Engineering & Design Embedded Software Design Mechanical Engineering & Design Industrial & Graphic Design Human Factors RBC Medical About Us Careers Blog Contact Us Privacy Terms of Use Follow Us ©Copyright 2020 - RBC Medical Innovations 13715 W 109TH Street, Lenexa KS 66215 • (855) 865-4711