We help medical device companies develop software and AI, validate safety and security, and navigate FDA regulations—all under one roof.
You need a strategy for bringing AI/ML-enabled software onto the US market.
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.
We guarantee AI/ML SaMD FDA submission and clearance in 9 months.
FDA identified major cybersecurity, software, or AI/ML deficiencies that you need help resolving.
We guarantee submitting your presub and BDD in 2 weeks.
We guarantee your BDD application in 2 weeks. Unlock funding, accelerate FDA review, and signal market leadership.
Notion-powered FDA-submission templates and drafting tool.
You need a product-development partner for an AI-enabled imaging application.
You need Quality Management System implementation and/or support.
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 need help preparing cybersecurity documents for an FDA submission or to respond to a Hold Letter.
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.
I learned more from an hour-long Innolitics sales call than an entire paid engagement from other consultants.
Richard Clark
Executive in Residence at Washington University