Medical Device Software Development and Testing
Our software engineers have extensive experience in navigating the specific regulations for FDA compliance. We’ve built numerous projects leading our customers to achieve IEC 62304, FDA 21 CFR, and HIPAA compliance. Let us make your approval experience a breeze.
- Global solutions
- In-home, hospital, corporate solutions
- Class II and Class III solutions
Medical Device Software Solutions
Software system to track clinical trial results enabling better reporting and contributing to health solutions
Reporting dashboards to allow companies to track and prioritize the health of their employees
Class II medical devices that monitor patients in ICUs to increase efficiency, visibility, and safety for healthcare workers
In the Business of Improving Lives Worldwide
From building Class II to Class III medical devices to reporting and more, we’ve helped companies make their mark in global healthcare in a variety of ways.
Class II medical devices continuously monitoring patients’ vitals from anywhere to give individuals more awareness and help with change management
How We Work
From Conception to Market
1. Explore fit
Our team meets with yours to understand how you work, your business, your project needs, and how our teams will work together. This includes an opportunity for you to personally interview our engineers for your project team.
2. Engineer solutions
Whether we are starting from scratch or joining a team mid-project, we’ll build a solution for you that’s secure, reliable, and impactful.
3. Ensure compliance
We take care to triple check that the solution we propose, build, and launch with you holds up to required regulations for use domestically and internationally.
Why Choose Integrant for Your Medical Device Needs?
We pride ourselves in already having the expertise you’re looking for and making the rigorous FDA approval process or FDA compliance maintenance as pain free as possible. We know you can’t expect the unexpected, but we’re always ready to roll up our sleeves and get you the results you’re looking for.
We’re easy to work with
From our first meeting to final launch and everything in between, we recognize the stress and challenges that come with FDA compliance on top of developing software. We work to integrate our team with yours in the way that is best for you whether that means adapting to your internal policies or bringing over some of our own. Think of us as chameleon-gineers.
We’re all about project stability
Medical device projects often involve complicated domains and high-risk products. Programs like our 4Plus1 Shadow Engineering Program ensure we always have extra engineers up to speed on your project at no cost to you whenever you need them. This saves ramp-up time and gives you peace of mind that your project is in good hands.
We’re transparent
This means you’ll always have visibility on your project. It also means we aren’t afraid to make recommendations that are in your best interest—even if that means less scope or fewer hours for us. We’re invested in guaranteeing you get the exact solution you need, especially when it comes to high-stakes projects like medical devices.
We’re one team
We’re collaborative and we love seeing our clients succeed. We do everything in our power to make that happen. Our engineers come to work dedicated to your goals and strive toward helping you make the biggest impact possible.
Our skills extend beyond technologies
Sure, we have the technical skills and FDA and medical device experience and expertise to help your project succeed. But we also never give up on solving a problem and are continuously improving. We work to truly understand you and your needs to engineer the perfect requirements. We have passion and grit that we feel is unique.