We can help you get your medical device onto the market as quickly as possible.
If you’re looking for a development partner for your Software as a Medical Device (SaMD), we can provide a turn-key development solution—user interface design, development, validation, documentation, and maintenance. Our development process is IEC 62304 compliant—the software development life cycle standard accepted in the US and EU. Here is our Software Development Plan template, which is generated by our RDM platform.
If you have a software team, our engineers can work with them and follow your existing procedures. If you haven’t development processes in place, we can help establish them and train your team to follow them.
If you have a hardware team, we can work with them. Several of our engineers have hardware experience, so they’ll find we’re easy to communicate with.
If you’re looking for a part-time interim CTO while you find funding, we can help here too. We can help define your software development strategy and field investor questions.
We have expertise with these technologies:
We also have worked with the following, although less often:
We also have some additional expertise in the field of medical imaging:
Focus on your product—don’t be sidetracked mastering FDA regulations, guidance documents, ISO standards, and HIPAA.
As part of our software development process, we produce all of the software documents required for premarket submissions. Some of the more important documents include:
For simple SaMD submissions, we can handle the entire 510(k) submission. For more complex submissions, we have relationships with several talented regulatory and quality consultants.
We’ve completed 510(k)s for medical device with AI algorithms. We can help you do the same.
Have you been putting off setting up your QMS?
We can help you set up a simple QMS designed for small SaMD manufacturers.
We understand some of the unique challenges researchers face.
It’s challenging to start a company while balancing teaching and research duties. We can help relieve some of the time-burden. After an initial burst of requirements-gathering, design, and hazard analysis, we can usually keep our interactions to a weekly one-hour meeting.
We can help write SBIR grants and provide letters of support. (We’ve helped three of our clients win Phase I and Phase II grants.)
For many of the researchers we work with, this is their first time starting a company. It’s also often personal—the culmination of years of research. And maybe it’s your retirement fund too. We can provide business strategy support in addition to our technical development.