Medical Device Software Development & Regulatory Services

We help companies develop and secure FDA/MDR approval for medical device software. Whether you're looking for consulting, help with a project, or a full-service partner—we are here to help.

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Trust in Innovation
at the Edge

Life Sciences is a rapidly-changing sector in terms of the patient needs it addresses, the technology it uses and the regulatory environment in which it operates. At BlueBridge Technologies, we’re particularly adept at responding quickly to those changes because we’ve been bridging the gap between science and technology since 2006.

Today, we work on the edge of innovation to design, develop and deliver intelligent components for all parts of your connected medical-device ecosystem. We work with the biggest names in global med-tech and pharma to produce adaptive, regulated systems and software that help manage chronic conditions. But most importantly, we change the lives of those with them.

Digital Therapeutics

Digital Diagnostics

Digital Medical Devices

Our Expertise

From mechanical engineering to data science, we use our knowledge, experience and passion to develop networked medical-device technology effectively and securely. We love nothing more than cracking your complex technical challenges, while ensuring that our efforts solve real-world problems and have real utility in the clinical domain. We work with discrete technologies (biosensors, connectivity, algorithms), systems integration and software architecture to help our clients develop existing products for the digital worlds, develop digital strategies and architect connected ecosystems. In order to deliver on our goal of revolutionising digital-health, we work across a number of different areas of expertise.

Cloud (SaMD)

Mobile (SaMD)

Device/Wearable

EXPLORE THEM

Our Customers Include

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Regulatory Compliance

We have achieved compliance with ISO 14971, ISO 13485, and ISO 62304 standards, which demonstrate our unwavering commitment to quality, safety, and excellence in the medical device industry. ISO 14971 ensures robust risk management, ISO 13485 confirms the highest standards in our quality management system, and ISO 62304 attests to our dedication to safe and effective medical device software development. Our compliance with these rigorous standards underscores our dedication to delivering superior products that prioritize patient safety and meet the stringent regulatory requirements of the healthcare sector.

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Testimonials

“

I did want to take the opportunity to thank the entire BBT team for your support….
I don't think there is anything more in the time given that you could have done for Vertigenius.
… the professionalism, pragmatism, quality and timely delivery of the work has been superb.
… I believe we have found a great partner in BBT and look forward to continuing to work with you over many projects in the future.

Mark Barry, CEOVertigenius

Get In Touch

Do you have a burning need to accelerate entry into the market for digital?
Are you looking for a fast, responsive and proven partner that can take on the end-to-end solution provision? If so, all you have to do is contact us to get started.

SAY HELLO