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 have a nearly finished product but no documentation, and need to submit a 510(k) ASAP.
You need help developing a new AI/ML-enabled medical device from scratch or an existing prototype.
You need a software-development partner for a new or existing medical-device product.
FDA identified major cybersecurity, software, or AI/ML deficiencies that you need rapid, experienced help resolving.
You need guidance, training, templates, and document review support for a 510(k) submission.
You need to determine the best path to the US market or have other custom regulatory needs.
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.
Cofounder of AUMI AI
CEO of Rology
Associated VP at Varian Medical Systems
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.