Companies like yours create
medical device software with Innolitics

We likely wouldn't have received our Breakthrough Device Designation without Innolitics. When FDA initially pushed back, they quickly understood the concerns and responded with clear, well-supported data. Their expertise in software, medicine, and FDA's AI/ML expectations made a decisive difference in the outcome.

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. Every step of the way, Innolitics demonstrated why they’re leaders in medical software development.

They were proactive, informative, and very well-versed in the regulatory challenges of AI in medical imaging… Unlike competitors, who sometimes take a blanket approach, Innolitics didn't throw the baby out with the bathwater. They recognized the good work already done and built upon it… We reviewed other capable firms, but none showed the same depth of understanding of the rapidly evolving landscape of AI and regulatory requirements. Their proactive stance with the FDA gave us confidence that we were in the right hands, compared to competitors who seemed more reactive.

We recently got FDA cleared and Innolitics' responses were absolutely clutch to craft the strategy that finally worked. Unlike other consultants, who wanted us to do more work and spend more money on clinical testing, Innolitics found a path of least resistance using a combination of our existing validation and thoughtful responses to FDA. We received the best Christmas present ever – our 510(k) clearance letter.

We partnered with Innolitics to improve and update our team’s analysis software. They have diligently worked to add new features and address the troubled areas of the code to both improve its efficiency, as well as its usability. They work independently solving problems and handling difficult coding situations to deliver quality changes and improvements. These improvements have streamlined our code into a more powerful and concise use interface.

We really enjoyed working with Innolitics in reviewing our cybersecurity related documentation and compiling a response to the FDA. We were particularly impressed with their knowledge and expertise in the field, and quick turn-around times to our queries. We look forward to working with Innolitics on future projects.

During a presubmission meeting, the FDA acknowledged that Innolitics were "extremely advanced" in their understanding of the regulations. The FDA essentially concurred with all of Innolitics' advice, demonstrating a deep understanding of the regulations, even in the face of ambiguous topics such as CADe vs non-CADe. They expertly, and politely, navigated the FDA call with our best interests in mind while fostering a collaborative exchange with the agency.

Innolitics' team epitomized proficiency, professionalism, and precision. Their expertise extends beyond FDA regulations, encompassing intricate facets of DICOM, radiology workflows, and adept software engineering. Venturing into this without their support would have potentially stretched our timeline to 9 months or more. Earning the FDA clearance (K231385), for us, is more than just an accomplishment; it's a monumental milestone.

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. Every step of the way, Innolitics demonstrated why they’re leaders in medical software development.

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.

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.

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.

I worked with Innolitics to develop an application that analyzes MR images of our geometric distortion phantoms. It was a quite challenging image-processing project. In the end my company and Innolitics team were able to meet the challenge and built a quality web UI and a robust analysis pipeline. Innolitics seems like a company that is run by engineers who care about doing quality work.

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.

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.

I am superbly impressed by the team at Innolitics. They were able to create a complex medical web application on efficiently and with high quality standards. I was not only impressed with their technical know-how, but also by their excellent communication skills.

Innolitics has been invaluable in developing some components of our cloud-based analysis software for preclinical imaging. They expertly implemented an AI tool for the analysis of DICOM data and helped us with training and optimizing a prototype neural network. Their developers work independently, handling complex challenges with ease, and deliver top-quality results. It's been a pleasure working with the dedicated and professional team at Innolitics, and we highly recommend their services.