Software Development Services
Navigating Medical Device Software Standards
As you develop your medical device software, whether it’s embedded or “SaMD” (Software as a Medical Device), you know that there are standards you’re going to have to comply with, but you might not be aware of the specifics. You might not be aware of the path to get you most efficiently from point A to point B, or even that a roadmap can be made to help you get there. But that’s exactly what can be done.
Understanding Your Challenges
At in2being, we understand where you’re coming from. We’ve lived the startup life as employees and founders. You have to make your funding last until the next value inflection point so that you can raise more funds, and you want to save time wherever possible. You also want to go through as little hassle as possible during the FDA clearance process. And while there’s no magic bullet other than hard work applied strategically, it’s in that sense that we do have the solution to your software development and compliance woes.
The Importance of Strategic Development
And while you can certainly design the software yourself, or choose to hire developers to code it for you… either way, when it comes time to present it to the FDA, you’ll be glad you developed it in a way that doesn’t require you to orphan the software and start from scratch.
You see, coding is hard enough as it is… compliance is even harder still.
Key Considerations
There is much to consider: Software lifecycle, cybersecurity, 62304, level of concern, and more.
At in2being we use IEC 62304 and the FDA software lifecycle guidance to guide creation of your specific software development plan (SDP).
Addressing Cybersecurity
We’re also deeply involved in the emerging world of cybersecurity. FDA has recently made clear that safety and efficacy are no longer the only criteria for clearance. A reasonable assurance of cyber impenetrability is now required for devices that could potentially connect to the internet.
Schedule a call with us to discuss your project.
What to Expect from Us
As we work together, you can expect a customized software development plan (dovetailed with the rest of the development plan – we can drive hardware development, software development, or both).
Your software development plan will include:
- System overview
- Relationship to other plans needing development
- Applicable standards
- Testing activities
- Lifecycle phases of work
- Documentation requirements
- Architecture
- Detailed design steps
- Testing plans
- Unit
- Integration
- System
- Software maintenance plan pointers
- Software configuration management pointers
- Software problem resolution process pointers
- Software design change
We create documentation packages that you can confidently put in front of the FDA. Contact us today to discuss your project!
“in2being sets itself apart in this space because they have a broad array of talent, are reliable at hitting deadlines, and stay connected when concerns arise. They are always responsible, and are responsive quickly to calls and emails. They are an affable and dedicated team that seems to get along well with each other, too. After many previous interactions with similar companies, we feel that we have found gold in this group.”
–Dr. Thomas Floyd, University of Virginia
Let’s Get Started
Want to get started? Set up a time to discuss your project with us.