Class II Medical Device Software Development and Testing for a San Diego-based Company

Company Overview

Our client is a San Diego biotech company specializing in FDA approved Class II Medical Devices. This project, which we initially joined more than 5 years ago, is responsible for redesigning and manufacturing biomedical hardware that’s provided in hospitals in the United States and Europe. This hardware targets multiple areas of health including hematology, cancer monitoring and treatment, and more.

The software for this project is divided into two purposes:

  1. One software, connected via intranet, provides updates to the hardware
  2. The second software tracks maintenance activities for the hardware to ensure working devices prior to being used on patients

The Integrant team works with several stakeholders on the customer side to continue to build upgrades, implement new features, identify clear requirements, maintain FDA approval standards, and more. There are so many things we love about this project, especially the partnership we’ve formed with this client that has really helped empower us to bring the best ideas and solutions to the table to be a small part of the giant impact they have on the healthcare world.  


Medical Device Software Development, Automation Testing


.NET, C#, WPF, SQL, InstallShield  

Project Locations

Cairo, Egypt


Medical Device, Manufacturing

Customer Since


Integrant Team Structure  

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With almost 30 years of experience under our belts, we’ve seen the whole gambit of software development project challenges. We know the stakes are high when it comes to global health, and we don’t take that lightly. Our teams were able to come together and tackle the challenges below:  

Multiple Stakeholders

For this project, we work with 8-9 stakeholders across four departments. These departments help ensure the highest quality applications and working devices to best service the end user. These four departments also have differing priorities and needs. The challenge here is to balance each department’s needs and compromise on what leaves the backlog first.  

Changing Requirements and Scope Changes   

Some amount of change requirements or scope changes are expected on a project. For this project, when we were all set to begin work on the next release, a new set of features came up in an emergency situation for the current version of the medical device. This meant halting all work on the upcoming release and refocusing energy on new features that needed to get done with high quality and in a timely manner.  

Rigorous Standards and FDA Approval

When it comes to FDA approved software and medical devices, there is no room for error. Quality and uptime are important components to the livelihood of so many. In the past, significant amounts of time have gone into regression testing to guarantee the effectiveness of the medical device. In addition, becau  se an intranet is required to upgrade the device’s software (different than the internet upgrading the software on your iPhone or Android device), technicians’ training and reports become increasingly significant in pinpointing faulty equipment and/or software. 

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Like with every software project, we ran into a few challenges. We were able to remain calm, come up with a plan, pivot when needed, and provide quality results and solutions for this medical device company. We’re thankful to our client for being with us every step of the way so we can continue the journey successfully together.

Agile Practices, Alignment, and a Business Analyst  

While the development team practices a daily stand-up, our meetings with the client look a little different. To maximize effectiveness for this project, key stakeholders on the client side meet Mondays to align prior to meeting with Integrant employees three days mid-week. This helps facilitate priorities and move decisions along faster.

In addition, we added a Business Analyst, who has been instrumental in guaranteeing clear requirements that incorporate all necessary features. This has allowed the Technical Project Lead (TPL) to focus even more on quality code and the implementation of more efficient solutions like automated regression testing.  

Automated Regression Testing  

To improve the timing of new releases while still maintaining the same high standard for FDA approval, our team has begun to implement automated regression testing. This will allow new versions to be deployed more quickly without adding stress about the effectiveness and reliability of the device.  

Communication, Communication, Communication (and Impact and Status Reports)  

With challenges like scope changes and changing requirements, it’s important that our team understands what’s going on and we’re realistic about the impact that changes and other obstacles provide to a software development project. These impact analyses are key to communicating our project status and potential project needs in order to accomplish agreed upon goals.  
Not only are our engineers prepared for upcoming project changes or technology updates, but we like to be ready in case any project challenges come up. Doing a little more work up front to make sure we’re prepared and able to take on anything has been one key to our success. To stay one step ahead and manage challenges like scope changes or change requirements, we did the following:
1. Estimate requirements right away so we have them prepared even if we work on something else first
2. Keep an eye out for and communicate risks and challenges early 3. Always be two sprints ahead (and raise a flag if that’s not the case!) 4. Make sure TFS or Git boards are always up to date and well-managed. In this case, we had two boards to keep things crystal clear and this also allowed us to do work concurrently on both releases if needed. 

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We’re hard at work on the next release and we look forward to continuing our partnership on this project among the many others that we have ongoing with this client. We don’t take for granted our strong relationship and ability to work together toward a successful outcome.
If you’re looking for an outsource software development company with extensive experience with Class II Medical Devices and FDA approval, contact us today!  

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