We help companies create and FDA clear medical device software. Whether you're looking for consulting, help with a project, or a full-service partner—we can help.
You need a software-development partner for a new or existing medical-device product.
You need to determine the best path to the US market or have other custom regulatory needs.
You have a nearly finished product but no documentation, and need to submit a 510(k) ASAP.
You are preparing your own 510(k) and are looking for a real example to guide you.
You need help preparing cybersecurity documents for an FDA submission or to respond to a Hold Letter.
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.
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.