We help Medtech companies create and clear Software as a Medical Device (SaMD). Additionally, we can develop your regulatory strategy, build your software (including AI/ML and cybersecurity), draft your design documents, and submit your FDA 510(k).
You need a software-development partner for a new or existing medical-device product.
You need help developing a new AI/ML-enabled medical device from scratch or an existing prototype.
You need to determine the best path to the US market or have other custom regulatory needs.
FDA identified major cybersecurity, software, or AI/ML deficiencies that you need rapid, experienced help resolving.
You have a nearly finished product but no documentation, and need to submit a 510(k) ASAP.
You need guidance, training, templates, and document review support for a 510(k) submission.
Our team of software engineers and regulatory consultants has been helping medical device companies get onto the market since 2012. We operate at the intersection of software engineering and regulatory guidance.
We work with:
Don't take our word for it.
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.
Cofounder of AUMI AI
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.
CEO of Rology
Innolitics's engineers seamlessly integrate with our existing team. They’ve 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 (K153014) and is 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.
Associated VP at Varian Medical Systems
I needed a software development partner to write the software, train the AI, and get FDA clearance (K202229). 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.
Co-Founder at AI Metrics
Every great partnership starts with a conversation. Fill out the form below for a discovery call, and an Innolitics team member will contact you soon.