Our team specializes in medical device software. Since we focus on such a narrow domain, our team will be ready to hit the ground running. We know the FDA's medical device regulations and guidance for software devices. We know all of the latest software development tools and techniques that pertain to the medical device industry.
We can help you reach your next milestone faster. We work with companies at all stages, from ideation, to grant writing, to 510(k) submissions, to integrating with PACS and EHR systems.
We needed a team that would get it done right the first time and independently. As a physician, I was delighted to work with another physician engineer on the team that was able to implement complex clinical workflows with very little input from me or my team. Innolitics delivered ahead of schedule and exceeded expectations.
I needed a software development partner to write the software, train the AI, and get FDA clearance. An investor once told me that it would take me $5 million and 5 years to get to where we are now. Innolitics got me here 3 years ahead of schedule and $4 million dollars under budget.
I have really enjoyed working with the Innolitics team. We had originally enquired about the Innolitics DICOM conformance statement consulting but expanded them to augment the data engineering team. They helped build out a complex ETL pipeline for AI/ML and helped build out accompanying SOPs for regulatory compliance. They treat our product as if it was their own and integrate seamlessly with our in-house engineering team. Their breadth of knowledge in technical and regulatory matters has helped our team meet deadlines.
Innolitics is an incredible partner and consistently surpasses our
expectations. They have an extremely agile team, adapting to our needs
across back-end and front-end tasks seamlessly. When we needed support
around ISO 62304 compliance for FDA requirements, they jumped right in and
provided us compliant documentation. They also assisted us as we developed
a regulatory strategy around FDA Cybersecurity and HIPAA Compliance. The
Innolitics team is efficient, fair, and highly ethical. They are an
absolute pleasure to work with.
The work conducted by Innolitics to complete a complex software port of a
core module of our clinical product was outstanding. The clinical product
must by cleared by the FDA, and as such, we needed the highest quality
workmanship, and close collaboration with a dispersed team. Innolitics
performed exceedingly well in gathering requirements, researching,
developing and implementing a design, and providing test modules and
documentation. Their team's understanding of medical imaging analysis
software, and FDA quality processes, was key to the success of the project.
Innolitics's engineers seamlessly integrate with our existing team. Since
hiring them over a year ago, they have consistently produced high quality
work while helping us solve technical problems in the medical imaging
space. In particular, they spearheaded development of a large module that
extends our existing product suite. This module has since been cleared be
the FDA and is about to go live at hospitals around the world. Their work
on the module involved software development, researching various image
processing algorithms, analysis of these algorithms against real-world
data, and writing detailed technical documentation of the system that
justified its approach to the FDA.
We commissioned Innolitics to build a dashboard that integrated with our
radiation-oncology EMR. Their team’s clinical experience greatly
simplified communication and their perceptive questions and suggestions
helped us arrive at a better set of requirements for the project. The
final result was clean, easy for our doctors to use, and has already
improved the efficiency of our workflow.
At Apploi, we brought Innolitics on board to lead the development of an
ambitious infrastructure that was tightly coupled to a legacy database and
required a new Python API and a new Angular.js web app. Innolitics took
ownership of the project and exceeded our expectations, going above and
beyond to ensure the success of the project. What impresses me most is
that they treat our code base like their own. They were meticulous about
code quality, documentation, continuous integration, and keeping the
database schema clean and scalable! Innolitics was also a perfect fit for
us culturally, centered around tenacity, but with humility and seamless
I have worked with Innolitics for over three years developing complex and
innovative medical and financial applications. They've got some great
talent, a professional attitude and deliver on time under tight deadlines.
Their technical knowledge and design skills are strong, and they are an
enjoyable and creative team to work with.
We brought the Innolitics team on board to meet a tight launch deadline. They were able
to start contributing to our codebase quickly and with minimal guidance. They worked long
hours on short notice and were able to help us debug a number of tricky issues. We would
not have been able to launch on time without their assistance.
Dr. Sriram Vishwanath
The Scrum Group
I am superbly impressed by the team at Innolitics. They were able to create
a complex medical web application on very short notice and with high quality
standards. I was not only impressed with their technical know-how, but also
by their excellent communication skills. In fact I was so impressed that I
took the team out for beers.
Dr. Todd Wilson
University of Texas Physicians
I retained Innolitics to create a demonstration app for Android and iOS
platforms. They created an elegant design that resulted in a project that
was easy to understand and support. I was very impressed by their speed
and efficiency, I will definitely be hiring them again.