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

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Average Project Timeline Acceleration

Industry Leaders Choose RBC for Compliance with Medical Device Regulations

“My relationship with RBC spans three different companies and 15 years. I return to the RBC team because they consistently deliver innovative solutions in a timely and cost-effective manner. I plan to continue this relationship for many years to come!”

“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.”

We were a young start up with a great technology, but were running into issues that our manufacturing partner could not explain. Over a year later and still no clear solution, I engaged RBC to perform an independent analysis. Within 24 hours, they not only identified the issue, but also presented solutions to correct it. RBC came forward with the level of expertise that was necessary to help turn around the situation, allowing REACT to bring our advanced neuromuscular therapy to patients who need it.

“We were introduced to RBC during an acquisition. They were able to help define, develop proof-of-concept, prototype, fully develop, support in-vivo testing, certify, help gain regulatory approval and produce the first 100 units for a complex therapeutic device in less than two years. All of this in the midst of negotiating legal terms for the acquisition. I look forward to working with RBC on our next product!”

“We began our relationship with RBC for more than eight years to design and manufacture several radio frequency ablation medical devices. They have the staff, facilities and expertise to quickly produce the products we need, and the flexibility to respond to changes. I have counted on RBC to produce in several tough situations and they always come through.”

“I have worked with RBC on a complex electro-mechanical product and recommended them to several friends. As impressed as I am with their ability to quickly produce quality outputs, I am more impressed with how they handle unexpected situations. Anyone who knows medical device development knows there are always unexpected situations. I highly recommend anyone who is developing a new electronic product contact RBC.”

“We needed a firm with expertise in energy-based products and accessories. We approached RBC and found that not only did they have the expertise, but they had pre-made subsystems to accelerate and “de-risk” the program. I have since moved to a different part of the industry, but my former company continues to work with RBC to provide development and manufacturing services as well as subsystems. You cannot beat RBC for energy-based products!”

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: