Medical Device Software

Medical Device Software Development

As the years go by, industries across the world are relying on technological advancement more and more and the medical device industry is no different. Medical device software development presents unique struggles and challenges that need to be navigated by an experienced team. It’s no longer enough to build an adequate device. Software has become the new product differentiator.

At Barefoot Solutions, our medical device software development team understands these needs and works directly with you to help navigate the processes to ensure your medical device are compliant with the relevant regulatory entities like the FDA or HIPAA. We know firsthand the challenges associated with software development in the medical device space including compliance, quality control systems, device and software integration, and development lifecycle time and cost.


We know medical device software development compliance can be stressful and confusing. Not only do you have to get squared away with the FDA, but you also may have to be compliant with HIPAA, ISO 13485, and ISO 9001, or CFR 820, all of which have to be kept in mind during the development process. The good news is; we take care of all of that for you. We have years of experience helping our clients deal with compliancy issues and will work with you to navigate the process.

Why Barefoot Solutions?

Device and Software Integration

It doesn’t matter how great the software is if it doesn’t mesh with your device. At Barefoot Solutions, our medical device software development team has the software experience and hardware knowledge necessary to ensure our software integrates with your device seamlessly. We have a unique process that involves the creation of a desktop simulator to represent the hardware, allowing software and hardware teams to work in parallel without relying or waiting on the other. Our experience with IoT development lets you know that we don’t just talk the talk when it comes to device and software integration. We also maintain a rigorous testing schedule and communicate directly with you to keep the whole process moving along smoothly.

Development Cycle Time and Cost

Time is money and that’s never more true than during software development. We know that every delay costs you money which is why we’ve implemented a tried and true development process that saves time without sacrificing quality. We break medical device software projects down into three phases: conceptualization, design & development, and rollout with testing and regulatory documentation occurring during every stage. At Barefoot Solutions, we’ll help you work through FDA, HIPAA, ISO 13485, and ISO 9001 compliancy without any hiccups while ensuring our software makes your device function like never before.

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Check Out Some of Our Work


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To learn more, visit:

AUDIT Micro Controls

AUDIT MicroControls is a website dedicated to daily quality control and calibration verification/ linearity materials to laboratories worldwide at a fair price. Based on the Magento platform, it offers valuable customer service, easy to use data management tools, real-time data-reduction tools, and same-day shipping.

Visit for more information.

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Blue Sky Network is dedicated to developing and deploying innovative communication solutions that help their customers track their global fleets, resulting in improved safety, business efficiencies and profitability.


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