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

Medical Device Regulatory Support You Can Trust

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Years of Experience
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Largest Medical Device Companies Trust RBC
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of Customers Do Repeat Business
0 %
Average Project Timeline Acceleration

Industry Leaders Choose RBC for Compliance with Medical Device Regulations

Why Choose RBC for Medical?

Medical Device Project 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
Medical Device Certification Project Support
Need regulation and certification assistance?
Contact RBC’s experts to discuss regulatory consulting for medical device rates!

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

Invasive / Non Invasive Ventilator

Renal RF
Ablation System

Vascular Compression System

Intra-Aortic
Balloon Pump

Information
Management

Endoilluminator

Diagnostic Equipment

RF Puncture Generator

Bleed Monitoring system

Bleed Monitoring System

Pulsed Field Ablation

Pulsed Field Ablation

Nerve Tissue RF Ablation System

Medical Device Regulation and Certification Professionals